A Clinical Trial of Multiple Formulations of MK-4082 in Healthy Overweight and Obese Participants (MK-4082-007)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MK-4082 Formulation 1 (F1), MK-4082 Formulation 2 (F2), MK-4082 Formulation 4 (F4).
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study to Evaluate the Relative Bioavailability of Multiple Formulations of MK-4082 in Overweight/Obese Participants
Overview
Researchers are looking for new weight loss medicines for people with higher body weight. The study medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a study medicine to people with a health condition, researchers first do studies to find a safe dose level (amount) and formulation (version) of the study medicine that can be used in future studies. The goals of this study are to learn about: The safety of different formulations of MK-4082 and if people tolerate them What happens to different formulations of MK-4082 in a person's body over time
Interventions
- Drug MK-4082 Formulation 1 (F1)
Oral Tablet - Drug MK-4082 Formulation 2 (F2)
Oral Tablet - Drug MK-4082 Formulation 4 (F4)
Oral Tablet
Primary outcome measures
- Number of Participants Who Experience an Adverse Event (AE) [Time frame: Up to approximately 8 weeks]
- Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to approximately 6 weeks]
Secondary outcome measures (2)
- Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-4082 [Time frame: At designated timepoints (up to 24 hours postdose)]
- Plasma Concentration at 24 Hours (C24) of MK-4082 [Time frame: At designated timepoints up to 24 hours postdose]
Eligibility criteria
Inclusion criteria
The main inclusion criteria include but are not limited to the following:
- Is in good health
- Has a body mass index (BMI) between 25 and 40 kg/m\^2, inclusive and weighs 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 that may induce malabsorption, history of bowel resection >20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss
- Has an individual or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07748351 · 4082-007 · MK-4082-007