Trial Outcomes & Findings for A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001) (NCT NCT04583423)

Last Updated: 2025-07-17

Results Overview

The NASH Clinical Research Network (CRN) scoring system evaluated by Blinded Independent Central Review (BICR) was used to assess treatment response. The NASH CRN scoring scales were: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution was defined as a score of 0-1 for inflammation, 0 for ballooning, and any grade of steatosis.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

183 participants

Primary outcome timeframe

Week 52

Results posted on

2025-07-17

Participant Flow

Males and females with pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) aged 18 to 80 years (in Japan and Taiwan, aged 20 to 80 years were randomized in this study

Participant milestones

Participant milestones
Measure	MK-3655 50 mg Following a 2-week placebo run-in, participants received MK-3655 50 mg by subcutaneous (SC) injection once every 4 weeks (Q4W) for 52 weeks.	MK-3655 100 mg Following a 2-week placebo run-in, participants received MK-3655 100 mg by SC injection Q4W for 52 weeks.	MK-3655 300 mg Following a 2-week placebo run-in, participants received MK-3655 300 mg by SC injection Q4W for 52 weeks.	Placebo Following a 2-week placebo run-in, participants received placebo by SC injection Q4W for 52 weeks.
Overall Study STARTED	45	48	46	44
Overall Study Received 1st Dose	45	47	46	44
Overall Study COMPLETED	10	11	8	8
Overall Study NOT COMPLETED	35	37	38	36

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-3655 50 mg Following a 2-week placebo run-in, participants received MK-3655 50 mg by subcutaneous (SC) injection once every 4 weeks (Q4W) for 52 weeks.	MK-3655 100 mg Following a 2-week placebo run-in, participants received MK-3655 100 mg by SC injection Q4W for 52 weeks.	MK-3655 300 mg Following a 2-week placebo run-in, participants received MK-3655 300 mg by SC injection Q4W for 52 weeks.	Placebo Following a 2-week placebo run-in, participants received placebo by SC injection Q4W for 52 weeks.
Overall Study Lost to Follow-up	0	1	0	2
Overall Study Study Terminated by Sponsor	32	35	36	33
Overall Study Withdrawal by Subject	3	1	2	1

Baseline Characteristics

A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-3655 50 mg n=45 Participants Following a 2-week placebo run-in, participants received MK-3655 50 mg by SC injection Q4W for 52 weeks.	MK-3655 100 mg n=48 Participants Following a 2-week placebo run-in, participants received MK-3655 100 mg by SC injection Q4W for 52 weeks.	MK-3655 300 mg n=46 Participants Following a 2-week placebo run-in, participants received MK-3655 300 mg by SC injection Q4W for 52 weeks.	Placebo n=44 Participants Following a 2-week placebo run-in, participants received placebo by SC injection Q4W for 52 weeks.	Total n=183 Participants Total of all reporting groups
Age, Continuous	59.6 Years STANDARD_DEVIATION 8.9 • n=5 Participants	54.3 Years STANDARD_DEVIATION 12.3 • n=7 Participants	56.6 Years STANDARD_DEVIATION 11.3 • n=5 Participants	55.8 Years STANDARD_DEVIATION 10.1 • n=4 Participants	56.5 Years STANDARD_DEVIATION 10.8 • n=21 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	19 Participants n=4 Participants	87 Participants n=21 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	28 Participants n=7 Participants	23 Participants n=5 Participants	25 Participants n=4 Participants	96 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants	18 Participants n=4 Participants	60 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	34 Participants n=7 Participants	28 Participants n=5 Participants	25 Participants n=4 Participants	120 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	18 Participants n=7 Participants	16 Participants n=5 Participants	16 Participants n=4 Participants	65 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	28 Participants n=7 Participants	27 Participants n=5 Participants	26 Participants n=4 Participants	107 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Baseline Fibrosis Stage Stage 2	21 Participants n=5 Participants	22 Participants n=7 Participants	21 Participants n=5 Participants	21 Participants n=4 Participants	85 Participants n=21 Participants
Baseline Fibrosis Stage Stage 3	24 Participants n=5 Participants	26 Participants n=7 Participants	25 Participants n=5 Participants	23 Participants n=4 Participants	98 Participants n=21 Participants
Percent Liver Fat Content <20%	30 Participants n=5 Participants	23 Participants n=7 Participants	30 Participants n=5 Participants	31 Participants n=4 Participants	114 Participants n=21 Participants
Percent Liver Fat Content ≥ 20%	15 Participants n=5 Participants	25 Participants n=7 Participants	16 Participants n=5 Participants	13 Participants n=4 Participants	69 Participants n=21 Participants
Type 2 Diabetes Mellitus (T2DM) Yes	22 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	24 Participants n=4 Participants	96 Participants n=21 Participants
Type 2 Diabetes Mellitus (T2DM) No	23 Participants n=5 Participants	23 Participants n=7 Participants	21 Participants n=5 Participants	20 Participants n=4 Participants	87 Participants n=21 Participants
Region Japan	11 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	45 Participants n=21 Participants
Region East Asia excluding Japan	6 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	21 Participants n=21 Participants
Region Other	28 Participants n=5 Participants	31 Participants n=7 Participants	30 Participants n=5 Participants	28 Participants n=4 Participants	117 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Full Analysis Set (FAS) population, which consisted of all randomized participants who had at least 1 injection of study intervention and had at least 1 assessment

Outcome measures

Outcome measures
Measure	MK-3655 50 mg n=18 Participants Following a 2-week placebo run-in, participants received MK-3655 50 mg by SC injection Q4W for 52 weeks.	MK-3655 100 mg n=21 Participants Following a 2-week placebo run-in, participants received MK-3655 100 mg by SC injection Q4W for 52 weeks.	MK-3655 300 mg n=17 Participants Following a 2-week placebo run-in, participants received MK-3655 300 mg by SC injection Q4W for 52 weeks.	Placebo n=17 Participants Following a 2-week placebo run-in, participants received placebo by SC injection Q4W for 52 weeks.
Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 52 Weeks	16.7 Percentage of Participants	14.3 Percentage of Participants	17.6 Percentage of Participants	5.9 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 64 weeks

Population: All Participants as Treated (APaT) population, which included all randomized participants who received at least 1 injection of study intervention

An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

Outcome measures

Outcome measures
Measure	MK-3655 50 mg n=45 Participants Following a 2-week placebo run-in, participants received MK-3655 50 mg by SC injection Q4W for 52 weeks.	MK-3655 100 mg n=47 Participants Following a 2-week placebo run-in, participants received MK-3655 100 mg by SC injection Q4W for 52 weeks.	MK-3655 300 mg n=46 Participants Following a 2-week placebo run-in, participants received MK-3655 300 mg by SC injection Q4W for 52 weeks.	Placebo n=44 Participants Following a 2-week placebo run-in, participants received placebo by SC injection Q4W for 52 weeks.
Percentage of Participants Who Experienced an Adverse Event (AE)	73.3 Percentage of Participants	70.2 Percentage of Participants	76.1 Percentage of Participants	77.3 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: APaT population, which included all randomized participants who received at least 1 injection of study intervention

Outcome measures

Outcome measures
Measure	MK-3655 50 mg n=45 Participants Following a 2-week placebo run-in, participants received MK-3655 50 mg by SC injection Q4W for 52 weeks.	MK-3655 100 mg n=47 Participants Following a 2-week placebo run-in, participants received MK-3655 100 mg by SC injection Q4W for 52 weeks.	MK-3655 300 mg n=46 Participants Following a 2-week placebo run-in, participants received MK-3655 300 mg by SC injection Q4W for 52 weeks.	Placebo n=44 Participants Following a 2-week placebo run-in, participants received placebo by SC injection Q4W for 52 weeks.
Percentage of Participants Discontinuing Study Medication Due to an AE	2.2 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS population, which consisted of all randomized participants who had at least 1 injection of study intervention and had at least 1 assessment

LFC % was measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF) and evaluated by BICR. MRI-PDFF is a highly accurate noninvasive measure of the proportion of fat content of a tissue.

Outcome measures

Outcome measures
Measure	MK-3655 50 mg n=33 Participants Following a 2-week placebo run-in, participants received MK-3655 50 mg by SC injection Q4W for 52 weeks.	MK-3655 100 mg n=36 Participants Following a 2-week placebo run-in, participants received MK-3655 100 mg by SC injection Q4W for 52 weeks.	MK-3655 300 mg n=37 Participants Following a 2-week placebo run-in, participants received MK-3655 300 mg by SC injection Q4W for 52 weeks.	Placebo n=31 Participants Following a 2-week placebo run-in, participants received placebo by SC injection Q4W for 52 weeks.
Mean Percent Relative Reduction From Baseline in Liver Fat Content (LFC) After 24 Weeks	30.1 Percent Change Interval 17.5 to 42.7	30.0 Percent Change Interval 18.2 to 41.8	37.2 Percent Change Interval 25.5 to 48.8	11.0 Percent Change Interval -0.9 to 23.0

SECONDARY outcome

Timeframe: Week 52

Population: FAS population, which consisted of all randomized participants who had at least 1 injection of study intervention and had at least 1 assessment

Participants were evaluated with the NASH CRN scoring system with BICR with ≥1 stage improvement in fibrosis without worsening of steatohepatitis defined as no increase in the ballooning, inflammation, or steatosis scores.

Outcome measures

Outcome measures
Measure	MK-3655 50 mg n=18 Participants Following a 2-week placebo run-in, participants received MK-3655 50 mg by SC injection Q4W for 52 weeks.	MK-3655 100 mg n=21 Participants Following a 2-week placebo run-in, participants received MK-3655 100 mg by SC injection Q4W for 52 weeks.	MK-3655 300 mg n=17 Participants Following a 2-week placebo run-in, participants received MK-3655 300 mg by SC injection Q4W for 52 weeks.	Placebo n=17 Participants Following a 2-week placebo run-in, participants received placebo by SC injection Q4W for 52 weeks.
Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis Assessed With the NASH CRN Scoring System After 52 Weeks	22.2 Percentage of Participants	38.1 Percentage of Participants	29.4 Percentage of Participants	17.6 Percentage of Participants

SECONDARY outcome

Timeframe: Week 52

Population: FAS population, which consisted of all randomized participants who had at least 1 injection of study intervention and had at least 1 assessment

Participants with ≥2 point improvement in the NAS with ≥1 point improvement in inflammation or ballooning without worsening of fibrosis were assessed with the NASH CRN scoring system (evaluated by BICR). The NAS was calculated as the unweighted sum of the scores and ranges from 0-8 (highest activity).

Outcome measures

Outcome measures
Measure	MK-3655 50 mg n=18 Participants Following a 2-week placebo run-in, participants received MK-3655 50 mg by SC injection Q4W for 52 weeks.	MK-3655 100 mg n=21 Participants Following a 2-week placebo run-in, participants received MK-3655 100 mg by SC injection Q4W for 52 weeks.	MK-3655 300 mg n=17 Participants Following a 2-week placebo run-in, participants received MK-3655 300 mg by SC injection Q4W for 52 weeks.	Placebo n=17 Participants Following a 2-week placebo run-in, participants received placebo by SC injection Q4W for 52 weeks.
Percentage of Participants With ≥2 Point Improvement in NAS With ≥1 Point Improvement in Inflammation or Ballooning Without Worsening of Fbrosis by Histology (Evaluated by BICR) After 52 Weeks	33.3 Percentage of Participants	47.6 Percentage of Participants	35.3 Percentage of Participants	29.4 Percentage of Participants

Adverse Events

MK-3655 50 mg

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

MK-3655 100 mg

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

MK-3655 300 mg

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo

Serious events: 8 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MK-3655 50 mg n=45 participants at risk Following a 2-week placebo run-in, participants received MK-3655 50 mg by SC injection Q4W for 52 weeks.	MK-3655 100 mg n=47 participants at risk Following a 2-week placebo run-in, participants received MK-3655 100 mg by SC injection Q4W for 52 weeks.	MK-3655 300 mg n=46 participants at risk Following a 2-week placebo run-in, participants received MK-3655 300 mg by SC injection Q4W for 52 weeks.	Placebo n=44 participants at risk Following a 2-week placebo run-in, participants received placebo by SC injection Q4W for 52 weeks.
Cardiac disorders Sinoatrial block	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Eye disorders Cataract	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Colitis	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.2% 1/46 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/44 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Large intestine polyp	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Infections and infestations COVID-19 pneumonia	2.2% 1/45 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/44 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Infections and infestations Diverticulitis	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.2% 1/46 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/44 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Infections and infestations Pyelonephritis acute	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Calculus bladder	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.1% 1/47 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/44 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.

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 If publication activity was not directed by the Sponsor, the investigator agreed to submit all manuscripts or abstracts to the Sponsor before submission. This allowed the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER

Measure	MK-3655 50 mg n=45 participants at risk Following a 2-week placebo run-in, participants received MK-3655 50 mg by SC injection Q4W for 52 weeks.	MK-3655 100 mg n=47 participants at risk Following a 2-week placebo run-in, participants received MK-3655 100 mg by SC injection Q4W for 52 weeks.	MK-3655 300 mg n=46 participants at risk Following a 2-week placebo run-in, participants received MK-3655 300 mg by SC injection Q4W for 52 weeks.	Placebo n=44 participants at risk Following a 2-week placebo run-in, participants received placebo by SC injection Q4W for 52 weeks.
Investigations Weight increased	2.2% 1/45 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.1% 1/47 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	6.5% 3/46 • Number of events 3 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	6.7% 3/45 • Number of events 3 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.1% 1/47 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/44 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Increased appetite	4.4% 2/45 • Number of events 2 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	10.6% 5/47 • Number of events 5 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	8.7% 4/46 • Number of events 4 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/44 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	2.2% 1/45 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.1% 1/47 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	15.2% 7/46 • Number of events 11 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	2.2% 1/45 • Number of events 2 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	6.4% 3/47 • Number of events 3 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	8.7% 4/46 • Number of events 6 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	6.8% 3/44 • Number of events 4 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	2.2% 1/45 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/47 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	6.5% 3/46 • Number of events 3 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	4.5% 2/44 • Number of events 2 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	8.9% 4/45 • Number of events 5 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	14.9% 7/47 • Number of events 7 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	10.9% 5/46 • Number of events 5 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	6.8% 3/44 • Number of events 5 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	4.4% 2/45 • Number of events 2 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	6.4% 3/47 • Number of events 3 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.2% 1/46 • Number of events 2 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	9.1% 4/44 • Number of events 4 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
General disorders Pyrexia	4.4% 2/45 • Number of events 4 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	4.3% 2/47 • Number of events 2 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	4.3% 2/46 • Number of events 2 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	9.1% 4/44 • Number of events 5 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	8.9% 4/45 • Number of events 4 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	19.1% 9/47 • Number of events 11 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	10.9% 5/46 • Number of events 6 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	11.4% 5/44 • Number of events 5 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Infections and infestations Influenza	2.2% 1/45 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	6.4% 3/47 • Number of events 3 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/46 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/44 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	4.4% 2/45 • Number of events 2 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	8.5% 4/47 • Number of events 6 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	4.3% 2/46 • Number of events 2 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	0.00% 0/44 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	6.7% 3/45 • Number of events 3 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	4.3% 2/47 • Number of events 2 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.2% 1/46 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/45 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.1% 1/47 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.2% 1/46 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	6.8% 3/44 • Number of events 4 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Nervous system disorders Headache	4.4% 2/45 • Number of events 2 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.1% 1/47 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	10.9% 5/46 • Number of events 6 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	6.8% 3/44 • Number of events 4 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	4.4% 2/45 • Number of events 2 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	12.8% 6/47 • Number of events 8 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	13.0% 6/46 • Number of events 7 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 64 weeks All-cause mortality population included all enrolled participants. Serious Adverse Events (SAEs) and non-serious AEs population included all participants who received at least 1 dose of study drug.