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

NCT06352892 | Completed Phase 1 FDA Drug

• 1 other identifier: 20210201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Obesity; Overweight; AMG 133

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide

  Up to approximately 120 days

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

  Up to approximately 120 days

• AUC from Time Zero Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide

  Up to approximately 120 days

Secondary Outcomes (3)

• Number of Participants with Treatment-emergent Adverse Events

  Up to approximately 120 days

• Number of Participants with Serious Adverse Events

  Up to approximately 120 days

• Number of Participants with Anti-Maridebart Cafraglutide Antibodies

  Up to approximately 120 days

Study Arms (2)

Group 1: Maridebart Cafraglutide Dose 1

EXPERIMENTAL

Participants will receive a single SC lower dose of Maridebart Cafraglutide.

Drug: Maridebart Cafraglutide

Group 2: Maridebart Cafraglutide Dose 2

EXPERIMENTAL

Participants will receive a single SC higher dose of Maridebart Cafraglutide.

Drug: Maridebart Cafraglutide

Interventions

Maridebart Cafraglutide DRUG

Solution for SC injection.

Also known as: AMG 133

Group 1: Maridebart Cafraglutide Dose 1; Group 2: Maridebart Cafraglutide Dose 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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.
• Acetaminophen (paracetamol; up to 2 g per day) for analgesia will be allowed.
• Hormone replacement therapy (eg, estrogen, thyroid) will be allowed.
• Current or prior use of any glucagon-like peptide 1 agonist within the past 3 months prior to Check-in.
• All herbal medicines (eg, St. John's wort), Traditional Chinese Medicine herbs or formulations, 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 Sponsor.
• History of alcoholism or regular alcohol consumption of \>14 units per week for males and \>7 units for females or drug/chemical abuse within 1 year prior to Check-in.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, 000, Hong Kong

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Obesity; Overweight

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 8, 2024
• Study Start: April 25, 2024
• Primary Completion: August 27, 2024
• Study Completion: August 27, 2024
• Last Updated: January 8, 2026

Record last verified: 2026-01

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

HK (1)