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

NCT07832799 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 20240301
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide

  Up to Day 120

• Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Maridebart Cafraglutide

  Up to Day 120

• Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide

  Up to Day 120

Secondary Outcomes (2)

• Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events

  Up to Day 120

• Number of Participants With Anti-Maridebart Cafraglutide Antibodies

  Up to Day 120

Study Arms (2)

Maridebart Cafraglutide (Test)

EXPERIMENTAL

Participants will receive maridebart cafraglutide (test formulation) via subcutaneous (SC) injection.

Drug: Maridebart Cafraglutide

Maridebart Cafraglutide (Reference)

ACTIVE COMPARATOR

Participants will receive maridebart cafraglutide (reference formulation) via SC injection.

Drug: Maridebart Cafraglutide

Interventions

Maridebart Cafraglutide DRUG

Maridebart cafraglutide will be administered via SC injection.

Also known as: AMG 133, MariTide

Maridebart Cafraglutide (Reference); Maridebart Cafraglutide (Test)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start (Estimated): October 12, 2026
• Primary Completion (Estimated): March 23, 2027
• Study Completion (Estimated): March 23, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.