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A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight

A Phase 1, Open-label, Randomized, Parallel-group, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 133 Administered Subcutaneously in Chinese Subjects With Obesity or Overweight

NCT06352892•Amgen

View on ClinicalTrials.gov

Summary

The main objective of the study is to assess the pharmacokinetics (PK) of Maridebart Cafraglutide after a single subcutaneous (SC) administration in overweight or obese Chinese participants.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Provide signed informed consent.
•Participants must be of Chinese ancestry with biological parents and all 4 grandparents of Chinese ancestry.
•Male or female participants, between 18 and 65 years of age (inclusive) at the time of Screening. Female participants must be of nonchildbearing potential.
•Except for obesity, no clinically significant findings from medical history (that requires the use of medications and/or treatment), physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations.
•Body mass index between 24 and 40 kg/m\^2 (inclusive) at the time of Screening.
•Have a stable body weight (\<5 kg self-reported change) within 3 months before Screening.
•Have not modified diet or adopted any nutritional lifestyle modification for 3 months.

Exclusion Criteria

•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 or evidence, at Screening, of diabetes (regardless of type), based on Hemoglobin A1C of \> 7%.
•History or evidence of endocrine disorder (such as Cushing's Syndrome) that can cause obesity.
•Previous surgical procedure for obesity (excluding liposuction if performed \>1 year before study entry) within past 6 months from Check-in.
•History or current signs or symptoms of cardiovascular disease.
•History of clinically significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
•Estimated glomerular filtration rate less than at least 60 mL/min/1.73 m\^2 at Screening or Check-in.
•Alanine aminotransferase or aspartate aminotransferase \>2 x the upper limit of normal at Screening or Check-in.
•Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test at Screening. Participants whose results are compatible with prior immunity (vaccination or prior infection) may be included.
•Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before Check-in.
+14 more criteria

Locations (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Key Dates

Start Date

April 25, 2024

Primary Completion Date

August 27, 2024

Completion Date

August 27, 2024

Last Updated

January 8, 2026

Enrollment

ACTUAL participants

Conditions

Obesity

Interventions

Maridebart Cafraglutide

DRUG

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RECRUITINGNA

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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: January 8, 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.

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A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight

Inclusion Criteria

Exclusion Criteria

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