GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 24-40

Primary endpoints

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

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06352892

Org study ID20210201

Timeline

Milestones

Study first posted2024-04-08actual

Study start2024-04-25actual

Primary completion2024-08-27actual

Study completion2024-08-27actual

Last update posted2026-01-08actual

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.