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

ACTIVE_NOT_RECRUITINGPHASE1

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

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

NCT07226778•Amgen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (4)

Anaheim Clinical Trials

Anaheim, California, United States

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, United States

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, United States

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, United States

Key Dates

Start Date

October 10, 2025

Primary Completion Date

May 28, 2026

Completion Date

May 28, 2026

Last Updated

February 10, 2026

Enrollment

348

ACTUAL participants

Conditions

OverweightObesity

Interventions

Maridebart Cafraglutide

DRUG

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NCT01143454

Metabolic DiseaseObesity+4 more

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RECRUITINGNA

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NCT07472881

MenopausePerimenopause+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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