Trial Outcomes & Findings for Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016) (NCT NCT06482112)

Last Updated: 2026-06-01

Results Overview

Liver fat content (LFC) was measured with liver images taken by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) and analyzed by blinded independent central review (BICR). Relative Reduction from Baseline to Week 28 = (Baseline - Week 28) / Baseline x 100%. Least Squares (LS) Mean relative reduction from baseline in LFC is presented.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

124 participants

Primary outcome timeframe

Baseline and Week 28

Results posted on

2026-06-01

Participant Flow

Participants were randomized to 1 of 3 efinopegdutide regimen groups: 10 mg once weekly (Q1W), 10 mg every 2 weeks (Q2W), or 15 mg Q2W.

Participant milestones

Participant milestones
Measure	Efinopegdutide Q1W 10 mg Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 10 mg Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 15 mg Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks.
Overall Study STARTED	42	40	42
Overall Study Treated	42	39	42
Overall Study COMPLETED	39	35	34
Overall Study NOT COMPLETED	3	5	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Efinopegdutide Q1W 10 mg Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 10 mg Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 15 mg Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks.
Overall Study Exclusionary laboratory result	0	1	0
Overall Study Withdrawal by Subject	2	1	4
Overall Study Physician Decision	1	1	1
Overall Study Lost to Follow-up	0	2	3

Baseline Characteristics

Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Efinopegdutide Q1W 10 mg n=42 Participants Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 10 mg n=40 Participants Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 15 mg n=42 Participants Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks.	Total n=124 Participants Total of all reporting groups
Age, Continuous	47.6 years STANDARD_DEVIATION 11.9 • n=24 Participants	53.4 years STANDARD_DEVIATION 12.6 • n=24 Participants	50.8 years STANDARD_DEVIATION 13.8 • n=48 Participants	50.6 years STANDARD_DEVIATION 12.9 • n=100 Participants
Sex: Female, Male Female	27 Participants n=24 Participants	22 Participants n=24 Participants	28 Participants n=48 Participants	77 Participants n=100 Participants
Sex: Female, Male Male	15 Participants n=24 Participants	18 Participants n=24 Participants	14 Participants n=48 Participants	47 Participants n=100 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=24 Participants	23 Participants n=24 Participants	28 Participants n=48 Participants	79 Participants n=100 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=24 Participants	17 Participants n=24 Participants	13 Participants n=48 Participants	44 Participants n=100 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=24 Participants	1 Participants n=48 Participants	1 Participants n=100 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Asian	0 Participants n=24 Participants	2 Participants n=24 Participants	0 Participants n=48 Participants	2 Participants n=100 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Black or African American	4 Participants n=24 Participants	3 Participants n=24 Participants	4 Participants n=48 Participants	11 Participants n=100 Participants
Race (NIH/OMB) White	37 Participants n=24 Participants	32 Participants n=24 Participants	38 Participants n=48 Participants	107 Participants n=100 Participants
Race (NIH/OMB) More than one race	1 Participants n=24 Participants	1 Participants n=24 Participants	0 Participants n=48 Participants	2 Participants n=100 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	2 Participants n=24 Participants	0 Participants n=48 Participants	2 Participants n=100 Participants
Weight	105.5 kg STANDARD_DEVIATION 21.2 • n=24 Participants	108.4 kg STANDARD_DEVIATION 24.4 • n=24 Participants	101.8 kg STANDARD_DEVIATION 20.7 • n=48 Participants	105.2 kg STANDARD_DEVIATION 22.1 • n=100 Participants

PRIMARY outcome

Timeframe: Baseline and Week 28

Population: All randomized participants who received at least one dose of study intervention and have baseline data for the analysis.

Outcome measures

Outcome measures
Measure	Efinopegdutide Q1W 10 mg n=42 Participants Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 10 mg n=39 Participants Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 15 mg n=42 Participants Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks.
Mean Relative Reduction From Baseline in Liver Fat Content at Week 28	67.8 Percent Reduction Interval 60.7 to 74.9	54.4 Percent Reduction Interval 46.8 to 61.9	42.1 Percent Reduction Interval 34.6 to 49.5

PRIMARY outcome

Timeframe: Up to Week 32

Population: All randomized participants who received at least one dose of study intervention.

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who experienced an AE is presented.

Outcome measures

Outcome measures
Measure	Efinopegdutide Q1W 10 mg n=42 Participants Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 10 mg n=39 Participants Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 15 mg n=42 Participants Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks.
Percentage of Participants Who Experienced an Adverse Event (AE)	83.3 Percentage of participants	82.1 Percentage of participants	85.7 Percentage of participants

PRIMARY outcome

Timeframe: Up to Week 28

Population: All randomized participants who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	Efinopegdutide Q1W 10 mg n=42 Participants Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 10 mg n=39 Participants Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 15 mg n=42 Participants Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks.
Percentage of Participants Who Discontinued Study Intervention Due to an AE	7.1 Percentage of participants	5.1 Percentage of participants	9.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 28

Population: All randomized participants who received at least one dose of study intervention and have baseline data for the analysis.

Body weight in kilograms was measured using a standardized, digital scale. Mean percent change in body weight from Baseline to Week 28 = (Week 28 - Baseline) / Baseline x 100%. The LS mean percent change from baseline in body weight at 28 weeks is presented.

Outcome measures

Outcome measures
Measure	Efinopegdutide Q1W 10 mg n=42 Participants Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 10 mg n=39 Participants Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 15 mg n=42 Participants Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks.
Mean Percent Change From Baseline in Body Weight at Week 28	-7.5 Percent Change Interval -8.8 to -6.1	-3.9 Percent Change Interval -5.3 to -2.5	-4.1 Percent Change Interval -5.5 to -2.7

Adverse Events

Efinopegdutide Q1W 10 mg

Serious events: 3 serious events

Other events: 30 other events

Deaths: 0 deaths

Efinopegdutide Q2W 10 mg

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Efinopegdutide Q2W 15 mg

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Efinopegdutide Q1W 10 mg n=42 participants at risk Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 10 mg n=39 participants at risk Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 15 mg n=42 participants at risk Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks.
Cardiac disorders Supraventricular tachycardia	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/39 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.4% 1/42 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	2.4% 1/42 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/39 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Appendicitis	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/39 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.4% 1/42 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Bacteraemia	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/39 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.4% 1/42 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Ankle fracture	2.4% 1/42 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.6% 1/39 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Diabetic ketoacidosis	2.4% 1/42 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/39 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Lumbar radiculopathy	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.6% 1/39 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Hepatobiliary disorders Cholecystitis	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/39 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.4% 1/42 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER

Measure	Efinopegdutide Q1W 10 mg n=42 participants at risk Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 10 mg n=39 participants at risk Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.	Efinopegdutide Q2W 15 mg n=42 participants at risk Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks.
Gastrointestinal disorders Abdominal distension	11.9% 5/42 • Number of events 5 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/39 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.4% 1/42 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain	7.1% 3/42 • Number of events 3 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	5.1% 2/39 • Number of events 2 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	4.8% 2/42 • Number of events 2 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain upper	4.8% 2/42 • Number of events 3 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.6% 1/39 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	7.1% 3/42 • Number of events 3 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Constipation	26.2% 11/42 • Number of events 12 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	20.5% 8/39 • Number of events 8 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	28.6% 12/42 • Number of events 13 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	21.4% 9/42 • Number of events 10 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	7.7% 3/39 • Number of events 4 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	14.3% 6/42 • Number of events 7 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Dyspepsia	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	7.7% 3/39 • Number of events 4 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Eructation	7.1% 3/42 • Number of events 3 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.6% 1/39 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	7.1% 3/42 • Number of events 4 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Gastrooesophageal reflux disease	14.3% 6/42 • Number of events 7 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.6% 1/39 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	9.5% 4/42 • Number of events 4 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	33.3% 14/42 • Number of events 19 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	33.3% 13/39 • Number of events 19 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	47.6% 20/42 • Number of events 25 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	19.0% 8/42 • Number of events 9 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	17.9% 7/39 • Number of events 13 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	21.4% 9/42 • Number of events 11 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
General disorders Fatigue	9.5% 4/42 • Number of events 4 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.6% 1/39 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	9.5% 4/42 • Number of events 5 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
General disorders Injection site bruising	7.1% 3/42 • Number of events 3 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	5.1% 2/39 • Number of events 3 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	4.8% 2/42 • Number of events 2 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
General disorders Injection site pain	11.9% 5/42 • Number of events 16 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.6% 1/39 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	19.0% 8/42 • Number of events 36 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Sinusitis	2.4% 1/42 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.6% 1/39 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	7.1% 3/42 • Number of events 3 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Upper respiratory tract infection	2.4% 1/42 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	5.1% 2/39 • Number of events 2 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	7.1% 3/42 • Number of events 3 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Urinary tract infection	2.4% 1/42 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/39 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	7.1% 3/42 • Number of events 3 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Decreased appetite	16.7% 7/42 • Number of events 7 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	15.4% 6/39 • Number of events 6 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	11.9% 5/42 • Number of events 5 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	5.1% 2/39 • Number of events 2 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Dizziness	4.8% 2/42 • Number of events 2 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.6% 1/39 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	14.3% 6/42 • Number of events 8 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Headache	21.4% 9/42 • Number of events 13 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	5.1% 2/39 • Number of events 3 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	11.9% 5/42 • Number of events 12 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Psychiatric disorders Depression	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	5.1% 2/39 • Number of events 2 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Renal and urinary disorders Urinary incontinence	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	5.1% 2/39 • Number of events 2 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/42 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/39 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	7.1% 3/42 • Number of events 3 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash	7.1% 3/42 • Number of events 3 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/39 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.	2.4% 1/42 • Number of events 1 • Up to Week 32 All-cause mortality included all randomized participants. The analysis population for Serious and Other adverse events included all randomized participants who received at least 1 dose of study intervention.