Trial Outcomes & Findings for Long Term Extension Trial of Setmelanotide (NCT NCT03651765)

Last Updated: 2025-05-31

Results Overview

An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE was defined as any AE that began or worsened in intensity on or after the date of the first administration of study drug.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

205 participants

Primary outcome timeframe

From first dose up to 5.6 years

Results posted on

2025-05-31

Participant Flow

Participants from previous index trials (RM-493-011\[NCT02507492\], RM-493-012 \[NCT02896192\], RM-493-014\[NCT03013543\], RM-493-015 \[NCT03287960\], RM-493-023 \[NCT03746522\], RM-493-030 \[NCT04725240\], RM-493-034 \[NCT04963231\] with rare genetic, syndromic, or acquired diseases of obesity upstream of the Melanocortin-4 receptor (MC4R) in the melanocortin-leptin pathway and other abnormalities of the MC4R pathway and wished to continue with setmelanotide treatment were enrolled in this extension trial.

A total of 205 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	Setmelanotide Participants received setmelanotide at the same starting dose as received in the index trials as a subcutaneous (SC) injection once daily for up to 5.6 years in this extension trial.
Overall Study STARTED	205
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	116

Reasons for withdrawal

Reasons for withdrawal
Measure	Setmelanotide Participants received setmelanotide at the same starting dose as received in the index trials as a subcutaneous (SC) injection once daily for up to 5.6 years in this extension trial.
Overall Study Adverse Event	6
Overall Study Lack of Efficacy	18
Overall Study Lost to Follow-up	5
Overall Study Non-Compliance with Study Drug	4
Overall Study Physician Decision	6
Overall Study Pregnancy	1
Overall Study Discontinued by Sponsor	40
Overall Study Withdrawal by Parent/Guardian	6
Overall Study Withdrawal by Subject	24
Overall Study Miscellaneous	6

Baseline Characteristics

Long Term Extension Trial of Setmelanotide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Setmelanotide n=205 Participants Participants received setmelanotide at the same starting dose as received in the index trials as a SC injection once daily for up to 5.6 years in this extension trial.
Age, Continuous	22.7 Years STANDARD_DEVIATION 14.93 • n=99 Participants
Sex: Female, Male Female	125 Participants n=99 Participants
Sex: Female, Male Male	80 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	10 Participants n=99 Participants
Race (NIH/OMB) White	167 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	171 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	24 Participants n=99 Participants

PRIMARY outcome

Timeframe: From first dose up to 5.6 years

Population: SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.

Outcome measures

Outcome measures
Measure	Setmelanotide n=205 Participants Participants received setmelanotide at the same starting dose as received in the index trials as a SC injection once daily for up to 5.6 years in this extension trial.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	198 Participants

Adverse Events

Setmelanotide

Serious events: 27 serious events

Other events: 198 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Setmelanotide n=205 participants at risk Participants received setmelanotide at the same starting dose as received in the index trials as a SC injection once daily for up to 5.6 years in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Craniopharyngioma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage I	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Gastroenteritis Escherichia coli	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Pilonidal disease	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Pneumonia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Septic shock	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Suicidal ideation	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Hallucination, auditory	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Obsessive-compulsive disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Endocrine disorders Adrenocortical insufficiency acute	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Seizure	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Cerebrospinal fluid leakage	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Loss of consciousness	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Muscle spasticity	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Pancreatitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Small intestinal obstruction	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Malaise	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Pyrexia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Hepatobiliary disorders Bile duct stone	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Hepatobiliary disorders Cholecystitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hypoglycaemia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Ear and labyrinth disorders Deafness unilateral	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Angle closure glaucoma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Immune system disorders Anaphylactic shock	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Calculus bladder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Nephrolithiasis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Endometriosis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.

Other adverse events

Other adverse events
Measure	Setmelanotide n=205 participants at risk Participants received setmelanotide at the same starting dose as received in the index trials as a SC injection once daily for up to 5.6 years in this extension trial.
Infections and infestations Nasopharyngitis	15.6% 32/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Upper Respiratory Tract Infection	17.6% 36/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Covid-19	29.3% 60/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Influenza	10.7% 22/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Urinary Tract Infection	8.3% 17/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Gastroenteritis	7.3% 15/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Ear Infection	5.9% 12/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Bronchitis	3.9% 8/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Gastroenteritis Viral	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Viral Upper Respiratory Tract Infection	4.4% 9/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Otitis Media	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Sinusitis	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Pharyngitis	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Fungal Infection	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Pneumonia	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Laryngitis	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Oral Candidiasis	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Paronychia	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Pharyngitis Streptococcal	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Tonsillitis	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Respiratory Tract Infection	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Skin Infection	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Subcutaneous Abscess	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Viral Infection	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Body Tinea	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Conjunctivitis	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Lower Respiratory Tract Infection	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Onychomycosis	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Postoperative Wound Infection	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Tinea Versicolour	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Tooth Abscess	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Tooth Infection	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Vulvovaginal Candidiasis	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Abscess Limb	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Folliculitis	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Furuncle	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Gastrointestinal Candidiasis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Gastrointestinal Infection	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Gastrointestinal Viral Infection	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Gingivitis	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Implant Site Infection	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Oesophageal Candidiasis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Oral Herpes	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Otitis Externa	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Otitis Externa Fungal	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Pilonidal Disease	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Pulpitis Dental	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Rhinitis	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Vulvovaginal Mycotic Infection	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Wound Infection	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Acute Sinusitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Appendicitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Bacterial Vaginosis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Carbuncle	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Cellulitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Cystitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Eye Infection	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Gastrointestinal Fungal Infection	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Genital Candidiasis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Genital Herpes	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Groin Abscess	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Hand-Foot-And-Mouth Disease	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Herpes Simplex	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Herpes Zoster	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Hordeolum	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Infected Bite	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Injection Site Abscess	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Injection Site Cellulitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Lower Respiratory Tract Infection Bacterial	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Ludwig Angina	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Nail Infection	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Otitis Media Acute	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Parotitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Pericoronitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Pertussis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Post-Acute Covid-19 Syndrome	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Pustule	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Respiratory Syncytial Virus Infection	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Retinitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Skin Bacterial Infection	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Soft Tissue Infection	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Streptococcal Infection	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Systemic Viral Infection	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Tinea Pedis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Infections and infestations Tonsillitis Streptococcal	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	53.7% 110/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Acanthosis Nigricans	4.9% 10/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Acne	5.4% 11/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Eczema	5.4% 11/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Skin Depigmentation	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Alopecia	4.4% 9/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Dry Skin	3.9% 8/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Hidradenitis	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Skin Exfoliation	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Melanoderma	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Nail Pigmentation	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Papule	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Pruritus	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Rash	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Seborrhoeic Dermatitis	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Skin Hypopigmentation	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Skin Lesion	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Alopecia Areata	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Cafe Au Lait Spots	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Hair Colour Changes	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Urticaria	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Vitiligo	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Blister	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Erythema Ab Igne	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Intertrigo	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Nail Discolouration	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Perioral Dermatitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Photodermatosis	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Seborrhoea	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Skin Striae	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Actinic Keratosis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Dermal Cyst	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Ephelides	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Erythema Annulare	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Hand Dermatitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Hirsutism	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Ingrowing Nail	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Keloid Scar	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Keratosis Pilaris	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Lentigo	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Lichenification	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Nail Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Nail Ridging	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Neurodermatitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Psoriasis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Rash Erythematous	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Skin Discolouration	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Skin Fissures	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Skin Wrinkling	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Stasis Dermatitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Erythema	21.0% 43/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Induration	17.1% 35/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Pruritus	18.5% 38/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Fatigue	10.7% 22/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Pain	12.7% 26/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Bruising	12.2% 25/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Oedema	7.8% 16/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Pyrexia	7.3% 15/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Haemorrhage	5.9% 12/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Oedema Peripheral	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Haematoma	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Reaction	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Non-Cardiac Chest Pain	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Discolouration	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Asthenia	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Influenza Like Illness	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Illness	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Pain	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Application Site Erythema	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Chest Pain	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Feeling Cold	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Gait Disturbance	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Hangover	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Inflammation	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Irritation	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Chills	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Complication Associated With Device	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Fat Tissue Increased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Generalised Oedema	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Discharge	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Granuloma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Hypertrophy	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Mass	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Swelling	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Injection Site Urticaria	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Malaise	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Medical Device Site Haemorrhage	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Medical Device Site Pain	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Oedema	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
General disorders Vessel Puncture Site Haematoma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Nausea	13.7% 28/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Abdominal Pain Upper	9.8% 20/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Vomiting	10.2% 21/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Diarrhoea	8.3% 17/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Abdominal Pain	9.8% 20/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	4.9% 10/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Tongue Pigmentation	5.4% 11/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Dyspepsia	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Constipation	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Oral Pigmentation	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Abdominal Distension	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Gingival Hyperpigmentation	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Toothache	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Flatulence	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Abdominal Discomfort	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Dry Mouth	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Eructation	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Food Poisoning	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Gastritis	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Gingival Recession	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Haemorrhoids	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Tooth Impacted	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Abdominal Pain Lower	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Anal Fissure	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Dental Caries	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Eosinophilic Oesophagitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Frequent Bowel Movements	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Gastrointestinal Tract Mucosal Pigmentation	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Gingival Discolouration	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Gingival Pain	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Glossitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Glossodynia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Haematochezia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Large Intestine Polyp	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Lip Dry	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Lymphoid Hyperplasia Of Intestine	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Mouth Ulceration	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Odynophagia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Oesophageal Spasm	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Oesophagitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Oral Lichen Planus	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Periodontal Disease	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Rectal Discharge	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Swollen Tongue	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Tongue Coated	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Tongue Discolouration	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Gastrointestinal disorders Tooth Erosion	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Headache	29.3% 60/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Dizziness	7.8% 16/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Migraine	4.4% 9/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Seizure	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Syncope	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Disturbance In Attention	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Neuropathy Peripheral	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Paraesthesia	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Sciatica	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Dizziness Postural	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Lethargy	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Restless Legs Syndrome	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Sinus Headache	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Sleep Paralysis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Altered State Of Consciousness	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Bell's Palsy	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Carpal Tunnel Syndrome	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Cerebrospinal Fluid Leakage	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Dysarthria	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Facial Paralysis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Generalised Tonic-Clonic Seizure	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Nerve Compression	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Nystagmus	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Occipital Neuralgia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Ophthalmic Migraine	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Parosmia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Peroneal Nerve Palsy	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Petit Mal Epilepsy	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Presyncope	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Taste Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Tension Headache	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Nervous system disorders Tremor	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Alanine Aminotransferase Increased	6.3% 13/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Creatine Phosphokinase Increased	5.4% 11/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Gamma-Glutamyltransferase Increased	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Glycosylated Haemoglobin Increased	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Cholesterol Increased	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Triglycerides Increased	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations C-Reactive Protein Increased	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Hepatic Enzyme Increased	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Low Density Lipoprotein Increased	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Aspartate Aminotransferase Increased	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Bilirubin Increased	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Lactate Dehydrogenase Increased	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Thyroid Stimulating Hormone Increased	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations High Density Lipoprotein Decreased	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations White Blood Cell Count Increased	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Alkaline Phosphatase Increased	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Glucose Increased	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Pressure Increased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Glucose Urine Present	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations High Density Lipoprotein Increased	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Protein Urine Present	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Bilirubin Conjugated Increased	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Bicarbonate Decreased	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Insulin Increased	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Uric Acid Increased	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Sars-Cov-2 Test Positive	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Weight Increased	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Bicarbonate Increased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Calcium Decreased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Creatine Increased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Creatinine Increased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Iron Decreased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Magnesium Decreased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Oestrogen Decreased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Phosphorus Decreased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Potassium Decreased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Testosterone Increased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Urea Increased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Blood Urine Present	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Chest X-Ray Abnormal	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Crystal Urine Present	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Electrocardiogram Qt Prolonged	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Haematocrit Decreased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Haemoglobin Decreased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Irregular Heart Rate	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Leptin Level Increased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Liver Function Test Increased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Mammogram Abnormal	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Muscle Strength Abnormal	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Neutrophil Count Increased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Pregnancy Test Urine Positive	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Red Blood Cells Urine	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Transaminases Increased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Urinary Casts	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Urine Uric Acid Increased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations Weight Decreased	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations White Blood Cells Urine	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Investigations White Blood Cells Urine Positive	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Arthralgia	9.8% 20/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Pain In Extremity	7.8% 16/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Back Pain	9.8% 20/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Myalgia	3.9% 8/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Neck Pain	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Muscle Spasms	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Tendonitis	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Bursitis	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Foot Deformity	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Groin Pain	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Morphoea	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Pain In Jaw	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Scoliosis	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Arthritis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Discoid Meniscus	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Flank Pain	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Greater Trochanteric Pain Syndrome	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Growing Pains	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Joint Effusion	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Joint Hyperextension	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Joint Instability	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Ligament Pain	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Limb Discomfort	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Musculoskeletal Discomfort	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Osteitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Osteoporosis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Perthes Disease	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Spinal Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Spinal Stenosis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Tendon Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Immunisation Reaction	5.4% 11/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Fall	4.9% 10/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Contusion	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Ligament Sprain	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Foot Fracture	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Procedural Pain	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Skin Laceration	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Thermal Burn	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Concussion	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Muscle Strain	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Skin Abrasion	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Joint Dislocation	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Joint Injury	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Wound	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Arthropod Bite	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Limb Injury	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Meniscus Injury	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Post Procedural Fever	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Radius Fracture	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Scar	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Upper Limb Fracture	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Accidental Overdose	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Anaesthetic Complication Vascular	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Animal Scratch	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Bone Fragmentation	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Craniofacial Fracture	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Gingival Injury	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Hand Fracture	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Head Injury	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Human Bite	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Incision Site Rash	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Lip Injury	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Nerve Injury	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Sunburn	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Tendon Injury	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Tibia Fracture	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Tongue Injury	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Toxicity To Various Agents	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Traumatic Haematoma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Injury, poisoning and procedural complications Ulna Fracture	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Anxiety	4.4% 9/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Depression	4.9% 10/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Depressed Mood	4.4% 9/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Suicidal Ideation	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Insomnia	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Attention Deficit Hyperactivity Disorder	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Libido Decreased	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Libido Increased	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Panic Attack	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Stress	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Mood Altered	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Obsessive-Compulsive Disorder	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Aggression	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Depressive Symptom	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Intentional Self-Injury	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Adjustment Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Binge Eating	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Disturbance In Sexual Arousal	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Dysphoria	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Dyssomnia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Eating Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Emotional Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Negativism	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Sleep Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Psychiatric disorders Tension	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	6.3% 13/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 12/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.4% 9/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Asthma	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Bronchial Hyperreactivity	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Dyspnoea At Rest	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Nasal Crusting	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Discomfort	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Painful Respiration	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Pneumonitis Aspiration	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Respiratory, thoracic and mediastinal disorders Tonsillar Hypertrophy	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic Naevus	20.0% 41/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dysplastic Naevus	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic Keratosis	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Adenoma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Conjunctival Primary Acquired Melanosis	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Lung Neoplasm	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm Of Skin	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Craniopharyngioma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Eye Naevus	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma Of Breast	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteoma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary Tumour Benign	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Dysmenorrhoea	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Erection Increased	3.9% 8/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Menstruation Irregular	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Amenorrhoea	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Spontaneous Penile Erection	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Breast Cyst	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Postmenopausal Haemorrhage	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Spontaneous Ejaculation	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Uterine Haemorrhage	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Uterine Polyp	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Bartholin's Cyst	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Breast Fibrosis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Breast Pain	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Breast Swelling	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Breast Tenderness	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Dyspareunia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Ejaculation Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Endometriosis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Epididymal Cyst	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Erectile Dysfunction	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Genital Cyst	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Genital Discomfort	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Genital Hyperaesthesia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Heavy Menstrual Bleeding	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Intermenstrual Bleeding	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Menometrorrhagia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Menstrual Discomfort	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Oligomenorrhoea	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Ovarian Cyst	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Painful Erection	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Pelvic Pain	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Penile Plaque	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Polymenorrhoea	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Premenstrual Pain	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Testicular Torsion	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Vaginal Haemorrhage	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Vulva Cyst	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Reproductive system and breast disorders Vulval Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hypertriglyceridaemia	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Vitamin D Deficiency	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Dyslipidaemia	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Increased Appetite	2.4% 5/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Appetite Disorder	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Decreased Appetite	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Folate Deficiency	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Iron Deficiency	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hyperglycaemia	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hyperphagia	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hypoglycaemia	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Impaired Fasting Glucose	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Dehydration	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hypercholesterolaemia	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hyperkalaemia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hyperlipidaemia	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hyperphosphataemia	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Acidosis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Diabetes Mellitus	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Glucose Tolerance Impaired	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Gout	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hyperinsulinaemia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hypernatraemia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hypokalaemia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Hypophosphataemia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Lipoedema	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Metabolism and nutrition disorders Polydipsia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Dry Eye	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Cataract	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Eye Pain	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Corneal Pigmentation	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Eye Irritation	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Myopia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Scleral Pigmentation	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Blepharospasm	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Blindness	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Conjunctival Haemorrhage	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Conjunctival Pigmentation	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Conjunctivitis Allergic	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Eye Pruritus	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Eyelid Exfoliation	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Glaucoma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Macular Pigmentary Changes	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Meibomian Gland Dysfunction	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Retinopathy	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Swelling Of Eyelid	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Vision Blurred	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Visual Acuity Reduced	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Visual Impairment	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Eye disorders Vitreous Degeneration	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Ear and labyrinth disorders Ear Pain	3.4% 7/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Ear and labyrinth disorders Vertigo	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Ear and labyrinth disorders Hyperacusis	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Ear and labyrinth disorders Tinnitus	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Ear and labyrinth disorders Ear Discomfort	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Ear and labyrinth disorders Ear Disorder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Ear and labyrinth disorders Excessive Cerumen Production	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Ear and labyrinth disorders Inner Ear Inflammation	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Ear and labyrinth disorders Middle Ear Effusion	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Ear and labyrinth disorders Tympanic Membrane Perforation	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Ear and labyrinth disorders Vertigo Positional	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Bladder Pain	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Microalbuminuria	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Polyuria	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Haematuria	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Proteinuria	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Albuminuria	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Calculus Bladder	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Chronic Kidney Disease	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Dysuria	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Glomerulonephritis Membranoproliferative	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Glycosuria	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Lower Urinary Tract Symptoms	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Nephrolithiasis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Oliguria	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Pollakiuria	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Renal and urinary disorders Renal Impairment	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Blood and lymphatic system disorders Anaemia	3.9% 8/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Blood and lymphatic system disorders Eosinophilia	2.9% 6/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Blood and lymphatic system disorders Neutropenia	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Blood and lymphatic system disorders Lymphadenitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Blood and lymphatic system disorders Lymphadenopathy	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Blood and lymphatic system disorders Thrombocytosis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Vascular disorders Hypertension	5.4% 11/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Vascular disorders Hypotension	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Vascular disorders Lymphoedema	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Vascular disorders Scalp Haematoma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Hepatobiliary disorders Cholelithiasis	2.0% 4/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Hepatobiliary disorders Hyperbilirubinaemia	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Hepatobiliary disorders Hepatic Steatosis	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Hepatobiliary disorders Cholecystitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Hepatobiliary disorders Liver Opacity	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Hepatobiliary disorders Metabolic Dysfunction-Associated Liver Disease	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Hepatobiliary disorders Ocular Icterus	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Cardiac disorders Atrial Fibrillation	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Cardiac disorders Palpitations	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Cardiac disorders Sinus Tachycardia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Cardiac disorders Bradycardia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Cardiac disorders Cardiac Hypertrophy	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Cardiac disorders Tachycardia	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Endocrine disorders Hypothyroidism	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Endocrine disorders Adrenal Insufficiency	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Endocrine disorders Adrenocortical Insufficiency Acute	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Endocrine disorders Adrenomegaly	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Endocrine disorders Hyperthyroidism	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Endocrine disorders Polycystic Ovarian Syndrome	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Endocrine disorders Precocious Puberty	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Endocrine disorders Thyroid Stimulating Hormone Deficiency	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Immune system disorders Food Allergy	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Immune system disorders Seasonal Allergy	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Immune system disorders Drug Hypersensitivity	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Immune system disorders Hypersensitivity	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Congenital, familial and genetic disorders Retinitis Pigmentosa	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Congenital, familial and genetic disorders Hamartoma	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Dermatitis	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Drug eruption	0.98% 2/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Erythema	0.49% 1/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Macule	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Skin Plaque	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.
Skin and subcutaneous tissue disorders Solar lentingo	1.5% 3/205 • From first dose up to 5.6 years SAS included all participants who received at least one dose of received at least 1 dose of setmelanotide in this extension trial.

Additional Information

Rhythm Clinical Trials

Rhythm Pharmaceuticals, Inc.

Phone: 857-264-4280

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All information regarding setmelanotide supplied by Rhythm to the investigator is privileged and confidential information. The investigator agrees to use this information to accomplish the study and will not use it for other purposes without consent from Rhythm. The information obtained from the clinical study will be used towards the development of setmelanotide and may be disclosed to regulatory authority(ies), other investigators, corporate partners, or consultants as required.
Publication restrictions are in place

Restriction type: OTHER