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MK-3655 for Non-alcoholic Fatty Liver Disease

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 56 weeks
Awards & highlights

Study Summary

This trial will study whether MK-3655 can help resolve nonalcoholic steatohepatitis (NASH) without worsening liver fibrosis.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 56 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Discontinuing Study Medication Due to an AE
Percentage of Participants Who Experienced an Adverse Event (AE)
Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 52 Weeks
Secondary outcome measures
Mean Percent Change from Baseline in Liver Fat Content (LFC) After 24 Weeks
Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis Assessed With the NASH CRN Scoring System After 52 Weeks
Percentage of Participants With ≥2 Point Improvement in the Nonalcoholic Fatty Liver Disease Activity Score (NAS) Without Worsening of Fibrosis After 52 Weeks

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-3655 Middle DoseExperimental Treatment1 Intervention
MK-3655 middle dose by sc injection Q4W.
Group II: MK-3655 Low DoseExperimental Treatment1 Intervention
MK-3655 low dose by subcutaneous (sc) injection once every 4 weeks (Q4W).
Group III: MK-3655 High DoseExperimental Treatment1 Intervention
MK-3655 high dose by sc injection Q4W.
Group IV: PlaceboPlacebo Group1 Intervention
Matching placebo to MK-3655 by sc injection Q4W.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,641 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
186 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,366 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
631 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Medical Director, MDStudy DirectorMerck Sharp & Dohme LLC
76 Previous Clinical Trials
16,057 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
24 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the official regulatory stance on MK-3655?

"While there is some data supporting MK-3655's safety, it is still in Phase 2 of clinical trials and has not yet been proven effective. Therefore, it received a score of 2."

Answered by AI

Are there any open enrolment positions for this clinical trial?

"That is correct, the trial is currently ongoing and looking for 328 participants from 49 different sites. The listing was first posted on November 11th 2020 and last updated on November 3rd 2022."

Answered by AI

What are the investigators of this trial hoping to achieve?

"The primary outcome of this study is to evaluate the percentage of participants who discontinue study medication due to an adverse event. The secondary outcomes include the percentage of participants with at least a 1-stage improvement in fibrosis without worsening of steatohepatitis, as assessed by the NASH Clinical Research Network scoring system, and the percentage of participants with at least a 2-point improvement in the Nonalcoholic Fatty Liver Disease Activity Score (NAS) without worsening of fibrosis."

Answered by AI

Are there a number of research hospitals conducting this clinical trial in Canada?

"This clinical study is enrolling patients from 54 different locations, three of which are: Impact Research Institute in Waco, Texas; Texas Clinical Research Institute in Arlington, Florida; and Covenant Metabolic Specialists, LLC in Fort Myers, Arkansas."

Answered by AI

How many individuals are being sought for this clinical trial?

"In order to move forward with the study, 328 patients that meet specific clinical criteria are needed. The sponsor, Merck Sharp & Dohme Corp., will be running the trial from various locations including Impact Research Institute ( Site 2685) in Waco, Texas and Texas Clinical Research Institute ( Site 2619) in Arlington, Florida."

Answered by AI

For this particular experiment, are adults in their 80s being recruited?

"According to the eligibility guidelines, patients must be between 18-80 years old to take part in this particular trial. However, there are 24 other clinical trials available for minors and 203 studies open to adults over 65."

Answered by AI

How can I sign up for this clinical trial?

"This study needs 328 individuals aged 18-80 who have nonalcoholic steatohepatitis. Other inclusion criteria are as follows: no history of Type 2 diabetes mellitus (T2DM) OR controlled T2DM via diet or stable antihyperglycemic agent doses, male participants must use contraception consistently with local regulations, female participants cannot be pregnant/breastfeeding and must either not be a woman of child-bearing potential (WOCBP) OR a WOCBP using contraception that is highly effective during the intervention period + for 16 weeks post-last dose of study intervention, BMI ≥25 kg/m^2 and"

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Floridian Clinical Research, LLC ( Site 2656)
What portion of applicants met pre-screening criteria?
Met criteria
~42 spots leftby Apr 2025