ObesityPhase 1NCT06352892
A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight
A Phase 1 study testing Maridebart Cafraglutide in people with Obesity, run by Amgen at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Maridebart Cafraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Apr 2024to 27 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Maridebart Cafraglutide
- Keywords
- Obesity, Overweight, AMG 133
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maridebart CafraglutideDrug
Also called AMG 133
Solution for SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Maridebart Cafraglutide Dose 1 | Experimental | Participants will receive a single SC lower dose of Maridebart Cafraglutide. Receives: Drug: Maridebart Cafraglutide |
| Group 2: Maridebart Cafraglutide Dose 2 | Experimental | Participants will receive a single SC higher dose of Maridebart Cafraglutide. Receives: Drug: Maridebart Cafraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Measured: 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
Measured: Up to approximately 120 days
AUC from Time Zero Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide
Measured: Up to approximately 120 days
Secondary outcomes (3)
Number of Participants with Treatment-emergent Adverse Events
Measured: Up to approximately 120 days
Number of Participants with Serious Adverse Events
Measured: Up to approximately 120 days
Number of Participants with Anti-Maridebart Cafraglutide Antibodies
Measured: Up to approximately 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start25 Apr 2024
- Primary completion27 Aug 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352892
- Sponsor's protocol ID
- 20210201
- Status last verified
- Jan 2026
- First submitted
- 3 Apr 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06352892
- Acronym / sponsor ID
- 20210201
- Conditions
- Obesity
- Keywords
- Obesity, Overweight, AMG 133
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Maridebart Cafraglutide Dose 1 | Experimental | Drug: Maridebart CafraglutideParticipants will receive a single SC lower dose of Maridebart Cafraglutide. |
| Group 2: Maridebart Cafraglutide Dose 2 | Experimental | Drug: Maridebart CafraglutideParticipants will receive a single SC higher dose of Maridebart Cafraglutide. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maridebart CafraglutideAlso: AMG 133Solution for SC injection. | Drug | Group 1: Maridebart Cafraglutide Dose 1, Group 2: Maridebart Cafraglutide Dose 2 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Time frame: 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
Time frame: Up to approximately 120 days
AUC from Time Zero Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide
Time frame: Up to approximately 120 days
3 secondary outcomes
Number of Participants with Treatment-emergent Adverse Events
Time frame: Up to approximately 120 days
Number of Participants with Serious Adverse Events
Time frame: Up to approximately 120 days
Number of Participants with Anti-Maridebart Cafraglutide Antibodies
Time frame: Up to approximately 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Maridebart Cafraglutide in people with Obesity, run by Amgen at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide (time frame: Up to approximately 120 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.