NCT07226778CompletedPhase 1
Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) Presentations
A Phase 1, Open-label, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations in Participants Living With Overweight or Obesity
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 348 (actual)
- First submitted
- 7 Nov 2025
- Start date
- 10 Oct 2025
- Primary completion date
- 28 May 2026
- Lead sponsor
- Amgen
- Diseases
- Obesity
- NCT number
- NCT07226778
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 348
- From 10 Oct 2025 to the primary completion date, 28 May 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
- Current or prior use of all herbal medicines (eg, St. John's wort), 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 medical monitor, as appropriate.
- Participant has received a dose of an investigational drug within the past 30 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- Have previously completed or withdrawn from this study or any other study investigating maridebart cafraglutide or have previously received the investigational product.
Other illness
- 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 of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity.
- Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
- History or current signs or symptoms of cardiovascular disease (aside from controlled hypertension and controlled dyslipidemia), including but not limited to myocardial infarction, congenital heart disease, valvular heart disease, coronary revascularization, or angina.
- History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at screening or check-in.
- History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or their ingredients.
- Estimated glomerular filtration rate ≤60 mL/min/1.73 m\^2, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation at screening or check-in.
Lab values
- History of or active diabetes (regardless of type, with the exception of a history of gestational diabetes) or hemoglobin A1C ≥6.5% (≥48 mmol/mol).
- History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (\>2 x the upper limit of normal) at screening or a fasting serum triglyceride level of \>500 mg/dL at screening.
- Current use or prior use of any glucagon-like peptide-1 receptor (GLP-1R) agonist, or glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in.
Who the study is looking for
- Male or female, of any race, between 18 and 60 years of age, inclusive.
- Females must not be pregnant or lactating.
- Body mass index between ≥25.0 and \<40.0 kg/m\^2.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anaheim Clinical Trials Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Fortrea Clinical Research Unit - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Fortrea Clinical Research Unit - Daytona Beach Coordinator of this site? Confirm its status | Daytona Beach | United States | Unknown status |
| Fortrea Clinical Research Unit Inc. - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.