Trial Outcomes & Findings for Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants (NCT NCT01749137)
NCT ID: NCT01749137
Last Updated: 2023-08-14
Results Overview
The mean percent change from baseline in body weight at Day 90 was analyzed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
Baseline and Day 90
Results posted on
2023-08-14
Participant Flow
Participant milestones
| Measure |
Setmelanotide
Participants received 1 milligram (mg) setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
37
|
|
Overall Study
COMPLETED
|
22
|
26
|
|
Overall Study
NOT COMPLETED
|
15
|
11
|
Reasons for withdrawal
| Measure |
Setmelanotide
Participants received 1 milligram (mg) setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
Baseline Characteristics
Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants
Baseline characteristics by cohort
| Measure |
Setmelanotide
n=37 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=37 Participants
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.0 years
STANDARD_DEVIATION 9.77 • n=99 Participants
|
40.4 years
STANDARD_DEVIATION 11.72 • n=107 Participants
|
41.2 years
STANDARD_DEVIATION 10.74 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Body Weight
|
113.65 Kilograms
STANDARD_DEVIATION 16.074 • n=99 Participants
|
111.20 Kilograms
STANDARD_DEVIATION 10.031 • n=107 Participants
|
112.43 Kilograms
STANDARD_DEVIATION 13.362 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 90Population: FAS population with available data at specified time point.
The mean percent change from baseline in body weight at Day 90 was analyzed.
Outcome measures
| Measure |
Setmelanotide
n=33 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=36 Participants
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Percent Change From Baseline in Body Weight
|
-2.0 Percent change
Standard Deviation 2.82
|
-0.3 Percent change
Standard Deviation 2.96
|
SECONDARY outcome
Timeframe: Baseline and Day 90Population: FAS population with available data specified time point.
The mean change from baseline in body weight at day 90 was analyzed.
Outcome measures
| Measure |
Setmelanotide
n=33 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=36 Participants
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Change From Baseline in Body Weight
|
-2.2 Kilograms
Standard Deviation 3.39
|
-0.3 Kilograms
Standard Deviation 3.34
|
SECONDARY outcome
Timeframe: Baseline up to Day 90Population: FAS population with available data at specified time point.
The percentage of participants who lost ≥ 5% of their baseline body weight was analyzed. 95% confidence interval is calculated based on Clopper-Pearson.
Outcome measures
| Measure |
Setmelanotide
n=33 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=36 Participants
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Percentage of Participants Who Lost ≥ 5% of Their Baseline Body Weight
|
9.1 percentage of participants
Interval 1.9 to 24.3
|
5.6 percentage of participants
Interval 0.7 to 18.7
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and 2-hours post-infusion, Day 7, 14, 28, 56, and 90Population: The pharmacokinetic population included all participants who received any of the study drug infusion and have at least one post-dose safety assessment and who had evaluable plasma concentrations for RM-493.
Number of Participants Who Consistently Achieved Targeted Plasma Concentration of \~6 ng/mL were reported.
Outcome measures
| Measure |
Setmelanotide
n=37 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Number of Participants Who Consistently Achieved Targeted Plasma Concentration of ~6 Nanogram Per Milliliter (ng/mL)
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) until end of study (Up to 184 days)Population: The Safety Analysis Set consisted of all participants who received any of the study drug infusion and had at least one post-dose safety assessment.
An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An adverse event (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. A treatment-emergent AE was defined as an AE with an onset date on or after day 1.
Outcome measures
| Measure |
Setmelanotide
n=37 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=37 Participants
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events
|
75.7 percentage of participants
|
48.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: ABPM Completers population as participants who had both baseline and post-baseline assessment of ABPM parameters
Summary of individual average data at daytime, nighttime and 24 hours was reported.
Outcome measures
| Measure |
Setmelanotide
n=13 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=12 Participants
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Change From Baseline in Ambulatory Blood Pressure Monitoring Parameter (ABPM) - Systolic Blood Pressure
Daytime individual average
|
-2.45 millimeter of mercury (mmHg)
Standard Deviation 14.071
|
1.83 millimeter of mercury (mmHg)
Standard Deviation 12.200
|
|
Change From Baseline in Ambulatory Blood Pressure Monitoring Parameter (ABPM) - Systolic Blood Pressure
Night time individual average
|
-3.26 millimeter of mercury (mmHg)
Standard Deviation 13.310
|
1.24 millimeter of mercury (mmHg)
Standard Deviation 10.721
|
|
Change From Baseline in Ambulatory Blood Pressure Monitoring Parameter (ABPM) - Systolic Blood Pressure
24 hour (hr) individual average
|
-2.79 millimeter of mercury (mmHg)
Standard Deviation 13.174
|
1.61 millimeter of mercury (mmHg)
Standard Deviation 11.165
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: ABPM Completers
Summary of individual average data at daytime, nighttime and 24 hours was reported.
Outcome measures
| Measure |
Setmelanotide
n=13 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=12 Participants
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Change From Baseline in ABPM - Diastolic Blood Pressure
Daytime individual average
|
-1.62 mmHg
Standard Deviation 9.672
|
1.39 mmHg
Standard Deviation 5.591
|
|
Change From Baseline in ABPM - Diastolic Blood Pressure
Night time individual average
|
-0.96 mmHg
Standard Deviation 9.586
|
0.60 mmHg
Standard Deviation 5.184
|
|
Change From Baseline in ABPM - Diastolic Blood Pressure
24 hr individual average
|
-1.38 mmHg
Standard Deviation 9.261
|
1.09 mmHg
Standard Deviation 4.977
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: ABPM Completers.
Summary of individual average data at daytime, nighttime and 24 hours was reported.
Outcome measures
| Measure |
Setmelanotide
n=13 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=12 Participants
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Change From Baseline in ABPM - Mean Arterial Blood Pressure
Daytime individual average
|
-1.27 mmHg
Standard Deviation 10.886
|
1.70 mmHg
Standard Deviation 8.056
|
|
Change From Baseline in ABPM - Mean Arterial Blood Pressure
Night time individual average
|
-2.15 mmHg
Standard Deviation 10.589
|
0.86 mmHg
Standard Deviation 6.536
|
|
Change From Baseline in ABPM - Mean Arterial Blood Pressure
24 hr individual average
|
-1.65 mmHg
Standard Deviation 10.205
|
1.38 mmHg
Standard Deviation 7.018
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: ABPM Completers.
Summary of individual average data at daytime, nighttime and 24 hours was reported.
Outcome measures
| Measure |
Setmelanotide
n=13 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=12 Participants
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Change From Baseline in ABPM - Heart Rate
Daytime individual average
|
1.44 Beats per minute (BPM)
Standard Deviation 6.861
|
-1.90 Beats per minute (BPM)
Standard Deviation 8.702
|
|
Change From Baseline in ABPM - Heart Rate
Night time individual average
|
-0.28 Beats per minute (BPM)
Standard Deviation 8.293
|
0.05 Beats per minute (BPM)
Standard Deviation 10.420
|
|
Change From Baseline in ABPM - Heart Rate
24 hr individual average
|
0.70 Beats per minute (BPM)
Standard Deviation 6.703
|
-1.07 Beats per minute (BPM)
Standard Deviation 8.242
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: ABPM Completers.
Summary of individual average data at daytime, nighttime and 24 hours was reported.
Outcome measures
| Measure |
Setmelanotide
n=13 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=12 Participants
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Change From Baseline in ABPM - Pulse Pressure
Daytime individual average
|
-0.83 mmHg
Standard Deviation 6.320
|
0.44 mmHg
Standard Deviation 8.060
|
|
Change From Baseline in ABPM - Pulse Pressure
Night time individual average
|
-2.30 mmHg
Standard Deviation 6.038
|
0.65 mmHg
Standard Deviation 6.820
|
|
Change From Baseline in ABPM - Pulse Pressure
24 hr individual average
|
-1.41 mmHg
Standard Deviation 5.655
|
0.52 mmHg
Standard Deviation 7.366
|
SECONDARY outcome
Timeframe: Baseline and Day 90Population: FAS population with available data at specified time point.
The mean percent change from baseline in body weight in severely obese participants at Day 90 was analyzed.
Outcome measures
| Measure |
Setmelanotide
n=17 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=17 Participants
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Percent Change From Baseline in Body Weight in Severely Obese Participants
|
-2.3 Percent change
Standard Deviation 3.34
|
-0.7 Percent change
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: Baseline up to Day 90Population: FAS population with available data at specified time point.
The percentage of participants who lost ≥ 5% of their baseline body weight loss in severely obese participants was analyzed. 95% confidence interval is calculated based on Clopper-Pearson confidence interval.
Outcome measures
| Measure |
Setmelanotide
n=17 Participants
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=17 Participants
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Percentage of Participants Who Lost ≥ 5% of Their Baseline Body Weight in Severely Obese Participants
|
11.8 percentage of participants
Interval 1.5 to 36.4
|
11.8 percentage of participants
Interval 1.5 to 36.4
|
Adverse Events
Setmelanotide
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Setmelanotide
n=37 participants at risk
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=37 participants at risk
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
Other adverse events
| Measure |
Setmelanotide
n=37 participants at risk
Participants received 1 mg setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
Placebo
n=37 participants at risk
Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
|
|---|---|---|
|
Investigations
Blood pressure increased
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Reproductive system and breast disorders
Breast pain
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Reproductive system and breast disorders
Metrorrhagia
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Vascular disorders
Hypertension
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Vascular disorders
Phlebitis
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Endocrine disorders
Autoimmune thyroiditis
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Eye disorders
Dark circles under eyes
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Infections and infestations
Upper respiratory tract infection
|
8.1%
3/37 • Number of events 3 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
13.5%
5/37 • Number of events 5 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Infections and infestations
Cellulitis
|
8.1%
3/37 • Number of events 3 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Infections and infestations
Ear infection
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
5.4%
2/37 • Number of events 2 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Infections and infestations
Infusion site infection
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Infections and infestations
Skin infection
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Infections and infestations
Urinary tract infection
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
13.5%
5/37 • Number of events 5 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
24.3%
9/37 • Number of events 9 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.4%
2/37 • Number of events 2 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Acanthosis nigricans
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.7%
1/37 • Number of events 2 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Hypertrophic scar
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Gastrointestinal disorders
Nausea
|
13.5%
5/37 • Number of events 5 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
8.1%
3/37 • Number of events 3 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
5.4%
2/37 • Number of events 4 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
5.4%
2/37 • Number of events 2 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Investigations
Blood creatine phosphokinase increased
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Gastrointestinal disorders
Dry mouth
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Gastrointestinal disorders
Lip swelling
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Gastrointestinal disorders
Teething
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Gastrointestinal disorders
Tongue discolouration
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
General disorders
Thirst
|
5.4%
2/37 • Number of events 2 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
General disorders
Application site dermatitis
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
General disorders
Application site erosion
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
General disorders
Application site erythema
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
General disorders
Application site haemorrhage
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
General disorders
Application site pain
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
General disorders
Application site pruritus
|
13.5%
5/37 • Number of events 5 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
General disorders
Chills
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
General disorders
Fatigue
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
General disorders
Infusion site discolouration
|
2.7%
1/37 • Number of events 2 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
General disorders
Infusion site pruritus
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
General disorders
Injection site pruritus
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Nervous system disorders
Headache
|
10.8%
4/37 • Number of events 4 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Nervous system disorders
Lethargy
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Nervous system disorders
Sciatica
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
2/37 • Number of events 2 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.1%
3/37 • Number of events 3 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Psychiatric disorders
Anxiety
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Infections and infestations
Herpes zoster
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
|
Gastrointestinal disorders
Gum discoloration
|
2.7%
1/37 • Number of events 1 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
0.00%
0/37 • From first dose of study drug (Day 1) until end of study (Up to 184 days)
Safety Population
|
Additional Information
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