New obesity drug tested in chinese adults for first time
NCT ID NCT06352892
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tested a single injection of a new drug called AMG 133 (Maridebart Cafraglutide) in 20 overweight or obese Chinese adults. The main goal was to see how the drug moves through the body and to check for any safety issues. This is a first step to see if the drug might be a future treatment for obesity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Maridebart Cafraglutide (AMG 133)
- What this could lead to
- If successful, this could support further development of AMG 133 as a weight management option for people with obesity.
- What could go wrong
- This is a very early Phase 1 study with only 20 participants. It is designed to check safety and drug levels, not to prove weight loss. Many early-stage drugs do not advance to later trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Apr 2024
- Finished
-
Aug 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Queen Mary Hospital
Hong Kong, 000, Hong Kong
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Other studies related to the condition(s) this trial covers.
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