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Not Yet Recruiting NCT07832799

Comparing the Extent to Which Two Maridebart Cafraglutide Drug Products Are Made Available in the Body After a Single Subcutaneous Dose

Conditions: Overweight, Obesity

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 340
Sponsor: Amgen

Summary

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

Inclusion Criteria: * 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/m\^2). * Have a stable body weight within 3 months before screening. Exclusion Criteria: * 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. * Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ treated with curative intent, within the last 5 years. * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2. * History or current signs or symptoms of cardiovascular disease. * History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or its ingredients. * Estimated glomerular filtration rate ≤ 60 mL/min/1.73 m\^2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (2021) at screening or check-in. * Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in. * Current use or prior use of any glucagon-like peptide-1 receptor (GLP-1R) agonist, glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in. * Current or prior use of all herbal medicines, vitamins, and supplements consumed by the participant within the 30 days prior to check-in. * Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives, whichever is longer, prior to check-in. * Have previously completed or withdrawn from this study or any other study investigating maridebart cafraglutide or have previously received maridebart cafraglutide.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07832799). StuddyBuddy aggregates publicly available trial information.