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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Maridebart Cafraglutide

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 000
    • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

  1. Acetaminophen (paracetamol; up to 2 g per day) for analgesia will be allowed.
  2. 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.
• Alcohol consumption from 48 hours prior to Check-in and is unwilling to limit alcohol intake to a maximum of 1 unit/day on all other days, while not in the clinical research unit, from Screening through the End of Study (EOS) visit.
• Use of tobacco- or nicotine-containing products within 6 months prior to Check-in.
• Female participants with a positive pregnancy test at Screening or Check-in.
• Female participants lactating/breastfeeding or who plans to breastfeed during the study through 90 days after the EOS visit.
• Unwilling to adhere to contraceptive requirements through 90 days after the EOS visit.
• Male participants with a female partner of childbearing potential and not willing to inform his partner of his participation in this clinical study.
• Pregnant partner (of a male participant) or partner planning to become pregnant who is unwilling to practice abstinence (refrain from heterosexual intercourse) or use contraception while the participant is on study through 90 days after the EOS visit.
• Participant has received a dose of an investigational drug within the past 90 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Maridebart Cafraglutide Dose 1; Participants will receive a single SC lower dose of Maridebart Cafraglutide.	Drug: Maridebart Cafraglutide; Solution for SC injection.; Other Names: AMG 133
Experimental: Group 2: Maridebart Cafraglutide Dose 2; Participants will receive a single SC higher dose of Maridebart Cafraglutide.	Drug: Maridebart Cafraglutide; Solution for SC injection.; Other Names: AMG 133

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Actual): August 27, 2024
• Study Completion (Actual): August 27, 2024

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Overweight; AMG 133
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 20210201

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
• product manufactured in and exported from the U.S.: Yes