MK-4082 for healthy adults with higher body weight.
A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-4082 in Healthy Overweight/Obese Participants
PHASE1 · Merck Sharp & Dohme LLC · NCT07388667
This trial will test whether the oral pill MK-4082 is safe and how the body processes it in healthy people with BMI 25 to 40 kg/m^2.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC (industry) |
| Locations | 5 sites (Anaheim, California and 4 other locations) |
| Trial ID | NCT07388667 on ClinicalTrials.gov |
What this trial studies
This is a phase 1, interventional study in healthy overweight adults to examine safety, tolerability, and how different doses of MK-4082 behave in the body over time. Participants will receive either MK-4082 or placebo and will be monitored for side effects and drug levels. The study is conducted at multiple U.S. clinical sites and is designed to identify dose levels suitable for future studies. Results will inform whether MK-4082 can move into later-stage trials for weight management.
Who should consider this trial
Good fit: Ideal candidates are healthy adults who weigh at least 60 kg and have a BMI between 25 and 40 kg/m^2, with no major medical issues that would interfere with the study.
Not a fit: People with prior bariatric or other major GI surgery, significant gastrointestinal disorders, or a personal/family history of medullary thyroid carcinoma or MEN2 are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If MK-4082 is safe and well tolerated, it could become an oral option for weight management that avoids injections.
How similar studies have performed: Injectable GLP-1 drugs have shown clear weight-loss benefits and oral formulations (for example oral semaglutide) have shown promise, but MK-4082 as an oral agent is an early-stage, relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is in good health * Has body mass index (BMI) between 25 and 40 kg/m\^2, inclusive. Participants must weigh at least 60 kg Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * has a history of previous surgical treatment for obesity (bariatric surgery, gastric banding, etc.) or any other gastrointestinal (GI) surgery that may induce malabsorption, history of bowel resection \>20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss (including LAP-BAND®), as well as clinically significant GI disorders (eg, peptic ulcers, severe gastroesophageal reflux disease) * has an individual or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2
Where this trial is running
Anaheim, California and 4 other locations
- Anaheim Clinical Trials ( Site 0005) — Anaheim, California, United States (RECRUITING)
- ProSciento Inc. ( Site 0002) — Chula Vista, California, United States (RECRUITING)
- QPS-MRA, LLC ( Site 0003) — South Miami, Florida, United States (RECRUITING)
- Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0004) — Springfield, Missouri, United States (ACTIVE_NOT_RECRUITING)
- Hassman Research Institute Marlton Site ( Site 0006) — Marlton, New Jersey, United States (RECRUITING)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy