About this trial
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two maridebart cafraglutide drug products in participants living with overweight or obesity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants, of any race, between 18 and 60 years of age (inclusive).
Females must not be pregnant or lactating.
Body mass index of ≥ 25.0 to < 40.0 kilograms per square meter (kg/m²).
Have a stable body weight within 3 months before screening.
Disqualifiers
History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
History of or active diabetes (regardless of type, except history of gestational diabetes), or hemoglobin A1c ≥ 6.5%.
History or evidence of endocrine disorder that can cause obesity.
History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase or amylase (> 2 x upper limit of normal [ULN]) at screening or check-in, or fasting serum triglyceride level of > 500 milligrams per deciliter (mg/dL) at screening.
Trial design
Parallel
Treatments tested in this trial
Maridebart Cafraglutide
DrugMaridebart cafraglutide will be administered via SC injection.
Treatment groups
Trial outcomes
Primary outcomes
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Maridebart Cafraglutide
Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide
Secondary outcomes
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Number of Participants With Anti-Maridebart Cafraglutide Antibodies
Locations
This trial is not recruiting at the moment. You can still explore other options: