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

November 2, 2026 updated by: Amgen

A Phase 1, Open-label, Randomized, Parallel Group, Multiple Dose Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations in Participants Living With Overweight or Obesity

The main objective of this study is to compare the pharmacokinetics of maridebart cafraglutide administered as a single dose using two different subcutaneous (SC) presentations in participants with overweight or obesity after they have received escalating doses of the study drug.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

356

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults 18 to 60 years of age.
  • Body mass index (BMI) between 25 and 35 kilograms per square meter (kg/m^2), inclusive.
  • Stable body weight, with less than 5 kilograms (kg) (11 pounds) of weight change in the past 3 months.
  • No significant changes in diet or eating habits in the past 3 months.
  • Generally healthy. People with certain well-controlled medical conditions, such as sleep apnea, high blood pressure, high cholesterol, or underactive thyroid, may qualify if their treatment has been stable for at least 3 months and is approved by the study doctor.
  • Willing to follow the study's birth control requirements, if applicable, during the study and for the study-defined period after the last dose of study drug.
  • Able and willing to provide informed consent before participating in study procedures.

Exclusion Criteria:

  • History of diabetes or current diabetes, except diabetes during pregnancy, or blood sugar levels that meet the study's definition of diabetes.
  • Certain hormonal conditions that can cause weight gain, such as Cushing's syndrome.
  • History of pancreatitis (inflammation of the pancreas) or certain abnormal pancreatic blood test results.
  • History of cancer within the past 5 years, except certain early-stage cancers or nonmelanoma skin cancers.
  • Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2).
  • Uncontrolled thyroid disease or certain abnormal thyroid blood test results.
  • Significant stomach or intestinal conditions, including delayed stomach emptying, ulcers, or inflammatory bowel disease, or a history of certain digestive system surgeries.
  • Weight-loss surgery within the past 6 months.
  • Significant heart disease, abnormal heart rhythms, or blood pressure or heart rate outside the study's allowed limits.
  • Significant kidney or liver problems, or certain abnormal kidney or liver blood test results.
  • Positive tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, with certain exceptions for past hepatitis B vaccination or infection.
  • History of certain serious or unstable mental health conditions, self-injury within the past 5 years, or any previous suicide attempt.
  • History of ischemic optic neuropathy, a condition involving damage to the optic nerve caused by reduced blood flow.
  • Allergy or intolerance to maridebart cafraglutide (AMG 133), similar medications, or their ingredients.
  • Use of certain medications, including weight-loss or diabetes medications that act on glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP), within the restricted time periods before the study.
  • Use of certain herbal products, vitamins, or supplements within 30 days before enrollment, unless approved by the study doctor.
  • Recent participation in another investigational drug study or previous participation in a study of maridebart cafraglutide.
  • History of alcohol or drug abuse, recent illegal drug use, or positive alcohol or drug screening results not explained by permitted prescription medications.
  • Pregnant, breastfeeding, or planning to breastfeed during the study or within the study-defined period after the last dose of study drug.
  • Recent blood, plasma, or platelet donation within the study's restricted time periods.
  • Recent strenuous exercise or unwillingness to follow study restrictions on physical activity, alcohol, recreational drugs, diet, or other activities.
  • Difficulty providing blood samples because of poor vein access.
  • Any other medical condition, abnormal test result, or circumstance that the study doctor believes could make participation unsafe or interfere with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maridebart Cafraglutide: SC Presentation 1

Participants will receive maridebart cafraglutide administered subcutaneously (SC) during the initial dose-escalation period and, after randomization, will continue to receive maridebart cafraglutide SC administered using SC Presentation 1.
Drug: Maridebart cafraglutide

Administered subcutaneously.

Other Names:
  • AMG 133
  • MariTide
Experimental: Maridebart Cafraglutide: SC Presentation 2

Participants will receive maridebart cafraglutide administered SC during the initial dose-escalation period and, after randomization, will continue to receive maridebart cafraglutide SC administered using SC Presentation 2.
Drug: Maridebart cafraglutide

Administered subcutaneously.

Other Names:
  • AMG 133
  • MariTide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under the Plasma Concentration-time Curve from Time 0 to 28 days post dose (AUC 0-28) of Maridebart Cafraglutide
Time Frame: Up to 113 days
Up to 113 days
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Time Frame: Up to 113 days
Up to 113 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: TEAEs: From baseline (Day 1) up to end of trial (approximately 28 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 32 weeks)
TEAEs: From baseline (Day 1) up to end of trial (approximately 28 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 32 weeks)
Number of Participants Who Develop Anti-Maridebart Cafraglutide Antibodies
Time Frame: Baseline (Day 1) up to end of trial (approximately 28 weeks)
Baseline (Day 1) up to end of trial (approximately 28 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 9, 2026

Primary Completion (Estimated)

July 26, 2027

Study Completion (Estimated)

July 26, 2027

Study Registration Dates

First Submitted

November 2, 2026

First Submitted That Met QC Criteria

November 2, 2026

First Posted (Actual)

November 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20260175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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