MK-3655 for NASH

No longer recruiting at 229 trial locations

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Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme Corp.

Must be taking: Antihyperglycemic agents

Disqualifiers: Cirrhosis, Type 1 diabetes, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MK-3655, an experimental drug, to determine its effectiveness for individuals with pre-cirrhotic nonalcoholic steatohepatitis (NASH). NASH can cause liver damage, and the study aims to assess whether MK-3655 improves liver health compared to a placebo, which contains no active drug. Participants will receive varying doses of MK-3655 or a placebo through monthly injections for one year. The trial seeks individuals diagnosed with NASH who have a stable weight and do not have Type 1 diabetes or severe liver issues. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have Type 2 diabetes, your condition must be controlled by diet or stable doses of diabetes medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatment with MK-3655 is generally well-tolerated. Earlier studies found that patients experienced only mild side effects with this treatment. Some patients even showed a slight decrease in liver fat, which benefits those with liver issues like NASH. Overall, the evidence suggests that MK-3655 is safe, with no major safety concerns reported so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for NASH?

Researchers are excited about MK-3655 for pre-cirrhotic nonalcoholic steatohepatitis (NASH) because it targets the condition in a novel way. Unlike standard treatments that often focus on managing symptoms or complications, MK-3655 acts directly on metabolic pathways to address the root causes of NASH. This investigational drug is administered via subcutaneous injection every four weeks, which could offer a more convenient dosing schedule compared to some existing therapies. The potential for MK-3655 to directly influence metabolic dysfunction makes it a promising candidate for effectively treating NASH.

What evidence suggests that this trial's treatments could be effective for NASH?

Research has shown that MK-3655 can help lower liver fat in individuals with pre-cirrhotic nonalcoholic steatohepatitis (NASH). Earlier studies found that using MK-3655 for 24 weeks led to a small decrease in liver fat. This trial will evaluate different dosages of MK-3655—50 mg, 100 mg, and 300 mg—to further assess its effectiveness and safety. Most patients tolerated the treatment well in previous studies. Although more research is needed to confirm its efficacy, these early results are promising for people with NASH. ^{1 2 4 6 7}

Who Is on the Research Team?

Medical Director, MD

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

A female participant is eligible to participate in the study if she is not pregnant or breastfeeding, and she does not have a menstrual cycle.

Has histological confirmation of NASH

The subject either has no history of Type 2 diabetes mellitus or a history of T2DM that has been controlled by diet or stable doses of antihyperglycemic agents.

Exclusion Criteria

Has presence of cirrhosis on liver biopsy

Has Type 1 diabetes

Has a history of bariatric surgery ≤5 years before study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo Run-in

Participants receive placebo by SC injection to establish baseline

2 weeks

Treatment

Participants receive MK-3655 or placebo by SC injection every 4 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-3655
• Placebo

How Is the Trial Designed?

Group I: MK-3655 50 mg Experimental Treatment 1 Intervention

Following a 2-week placebo run-in, participants will receive MK-3655 50 mg by subcutaneous (SC) injection once every 4 weeks (Q4W) for 52 weeks.

Group II: MK-3655 300 mg Experimental Treatment 1 Intervention

Following a 2-week placebo run-in, participants will receive MK-3655 300 mg by SC injection Q4W for 52 weeks.

Group III: MK-3655 100 mg Experimental Treatment 1 Intervention

Following a 2-week placebo run-in, participants will receive MK-3655 100 mg by SC injection Q4W for 52 weeks.

Group IV: Placebo Placebo Group 1 Intervention

Following a 2-week placebo run-in, participants will receive Placebo by SC injection Q4W for 52 weeks.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11908112/

A Phase 2b Study to Evaluate the Efficacy and Safety of MK ... Treatment with MK-3655 was generally well tolerated and resulted in a modest reduction in liver fat content at 24 weeks.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04583423

A Study of MK-3655 in Individuals With Pre-cirrhotic ... This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39984821/

A Phase 2b Study to Evaluate the Efficacy and Safety of MK ... Conclusions: In patients with pre-cirrhotic MASH, treatment with MK-3655 resulted in a modest reduction in LFC at 24 weeks. Clinical trial number: EudraCT: 2019 ...

4. ctv.veeva.com ctv.veeva.com/study/a-study-of-mk-3655-in-individuals-with-pre-cirrhotic-nonalcoholic-steatohepatitis-nash-mk365500

A Study of MK-3655 in Individuals With Pre-cirrhotic ... This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis ...

5. researchgate.net researchgate.net/publication/389216860_Clinical_Trial_A_Phase_2b_Study_to_Evaluate_the_Efficacy_and_Safety_of_MK-3655_in_Individuals_With_Pre-Cirrhotic_MASH

(PDF) Clinical Trial: A Phase 2b Study to Evaluate the ... was generally well tolerated. Conclusions: In patients with pre- cirrhotic MASH, treatment with MK- 3655 resulted in a modest reduction in LFC at 24 weeks. Clin ...

6. merck.com merck.com/news/merck-exercises-option-for-ngm-bios-investigational-insulin-sensitizer-ngm313-for-the-treatment-of-nash-and-type-2-diabetes/

Merck Exercises Option for NGM Bio's Investigational ... MK-3655 (formerly known as NGM313) is a proprietary, investigational agonistic antibody that selectively activates the β-Klotho/FGFR1c receptor ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/23/NCT04583423/Prot_SAP_000.pdf

NCT number: NCT04583423 Document Date: 24-Aug-2022 Safety Endpoints. The safety data for MK-3655 to date has been described in detail in Section 2.2.2 and in the. IB. In support of the safety ...