> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/comparing-the-extent-to-which-two-maridebart-cafraglutide-d1f73100-a69a-4f15-b442-3b78d936d505 > Record changed: 2026-11-04 # Comparing the Extent to Which Two Maridebart Cafraglutide Drug Products Are Made Available in the Body After a Single Subcutaneous Dose NCT07832799 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) Participants 340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) Start date 2026-10-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Short title** Comparing the Extent to Which Two Maridebart Cafraglutide Drug Products Are Made Available in the Body After a Single Subcutaneous Dose Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Official title** A Phase 1, Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Two Maridebart Cafraglutide (AMG 133) Drug Products in Participants Living With Overweight or Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) ## Dates **Completion date** 2027-03-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **First posted** 2026-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Registry last updated** 2026-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Primary completion date** 2027-03-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Start date** 2026-10-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) ## Size and sites **Participants** 340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Planned participants** 340 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) ## Identifiers **Registry ID** NCT07832799 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **ClinicalTrials.gov ID** NCT07832799 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) ## Outcomes ### Primary outcomes 1. Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide Timeframe: Up to Day 120 2. Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Maridebart Cafraglutide Timeframe: Up to Day 120 3. Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide Timeframe: Up to Day 120 ### Secondary outcomes 1. Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Timeframe: Up to Day 120 2. Number of Participants With Anti-Maridebart Cafraglutide Antibodies Timeframe: Up to Day 120 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07832799) ## Related records ### Drugs (1) - [Maridebart cafraglutide](https://trialight.com/data/asset/maridebart-cafraglutide-ed4d163f-9dd6-42fa-9ba3-bc4358617867.md) ### Lead sponsors (1) - [Amgen](https://trialight.com/data/company/amgen-e0106b98-aeaf-49cc-b95a-04f4be619a07.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) ### Targets (2) - [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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