> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/comparing-the-extent-to-which-maridebart-cafraglutide-amg-08ed24ce-e84a-4705-878b-7c5ba6dcff09 > Record changed: 2026-10-13 # Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) Presentations NCT07226778 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) Participants 348 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) Start date 2025-10-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) ## Title and summary **Summary** The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Short title** Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) Presentations Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Official title** A Phase 1, Open-label, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations in Participants Living With Overweight or Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) ## Dates **Completion date** 2026-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **First posted** 2025-11-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Registry last updated** 2026-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Primary completion date** 2026-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Start date** 2025-10-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) ## Size and sites **Actual participants** 348 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Participants** 348 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) ## Identifiers **Registry ID** NCT07226778 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **ClinicalTrials.gov ID** NCT07226778 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) ## Outcomes ### Primary outcomes 1. Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide Timeframe: Up to Day 120 2. Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide Timeframe: Up to Day 120 3. Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide Timeframe: Up to Day 120 ### Secondary outcomes 1. Number of Participants with Treatment-emergent Adverse Events Timeframe: Up to Day 120 2. Number of Participants with Serious Adverse Events Timeframe: Up to Day 120 3. Number of Participants with Anti-maridebart Cafraglutide Antibody Formation Timeframe: Up to Day 120 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** No ### Inclusion criteria 1. Male or female, of any race, between 18 and 60 years of age, inclusive. a. Females must not be pregnant or lactating. 2. Body mass index between ≥25.0 and <40.0 kg/m^2. ### Exclusion criteria 1. History or evidence, at screening or check-in, 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. 2. History of or active diabetes (regardless of type, with the exception of a history of gestational diabetes) or hemoglobin A1C ≥6.5% (≥48 mmol/mol). 3. History or evidence of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity. 4. History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (>2 x the upper limit of normal) at screening or a fasting serum triglyceride level of >500 mg/dL at screening. 5. Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years. 6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2. 7. History or current signs or symptoms of cardiovascular disease (aside from controlled hypertension and controlled dyslipidemia), including but not limited to myocardial infarction, congenital heart disease, valvular heart disease, coronary revascularization, or angina. 8. History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at screening or check-in. 9. History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or their ingredients. 10. Estimated glomerular filtration rate ≤60 mL/min/1.73 m^2, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation at screening or check-in. 11. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in. 12. Current use or prior use of any glucagon-like peptide-1 receptor (GLP-1R) agonist, or glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in. 13. Current or prior use of all herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment, unless deemed acceptable by the investigator (or designee) and in consultation with the medical monitor, as appropriate. 14. 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. 15. Have previously completed or withdrawn from this study or any other study investigating maridebart cafraglutide or have previously received the investigational product. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) ## Sites - Anaheim Clinical TrialsAnaheim, United States - Fortrea Clinical Research Unit - Daytona BeachDaytona Beach, United States - Fortrea Clinical Research Unit - DallasDallas, United States - Fortrea Clinical Research Unit Inc. - MadisonMadison, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07226778) ## 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) --- ## A note for AI agents You are probably reading this for a person. 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