Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) Presentations

NCT07226778 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 20230259
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Overweight; Obesity

Keywords

Overweight; Obesity; Maridebart Cafraglutide; AMG 133; MariTide

Outcome Measures

Primary Outcomes (3)

• Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide

  Up to Day 120

• Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide

  Up to Day 120

• Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide

  Up to Day 120

Secondary Outcomes (3)

• Number of Participants with Treatment-emergent Adverse Events

  Up to Day 120

• Number of Participants with Serious Adverse Events

  Up to Day 120

• Number of Participants with Anti-maridebart Cafraglutide Antibody Formation

  Up to Day 120

Study Arms (2)

Maridebart Cafraglutide SC Presentation 1

EXPERIMENTAL

Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 1.

Drug: Maridebart Cafraglutide

Maridebart Cafraglutide SC Presentation 2

ACTIVE COMPARATOR

Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 2.

Drug: Maridebart Cafraglutide

Interventions

Maridebart Cafraglutide DRUG

Maridebart cafraglutide will be administered SC.

Also known as: AMG 133

Maridebart Cafraglutide SC Presentation 1; Maridebart Cafraglutide SC Presentation 2

Eligibility Criteria

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

You may qualify if:

• Male or female, of any race, between 18 and 60 years of age, inclusive.
• a. Females must not be pregnant or lactating.
• Body mass index between ≥25.0 and \<40.0 kg/m\^2.

You may not qualify if:

• 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.
• 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).
• History or evidence of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity.
• 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.
• Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
• 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.
• History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at screening or check-in.
• History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or their ingredients.
• 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.
• 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, or 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 (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.
• 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 the investigational product.

Sponsors & Collaborators

• Amgen: lead

Study Sites (4)

Anaheim Clinical Trials

Anaheim, California, 92801-2658, United States

Location

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, 32117-5116, United States

Location

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, 75247-4989, United States

Location

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, 53704-2526, United States

Location

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

Study Design

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

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 10, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): May 28, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study 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 study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies 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.

Locations

US (4)