Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) Presentations
NCT07226778
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Amgen
Start date
2025-10-10
Number of sites
- Summary
- 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.
- Short title
- Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) Presentations
- Official title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-05-28
- First posted
- 2025-11-10
- Registry last updated
- 2026-06-17
- Primary completion date
- 2026-05-28
- Start date
- 2025-10-10
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Amgen
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07226778
- ClinicalTrials.gov ID
- NCT07226778
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Basic science
- Masking
- No masking
Sources for study design
Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide
Timeframe: Up to Day 120
Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide
Timeframe: Up to Day 120
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Timeframe: Up to Day 120
Number of Participants with Treatment-emergent Adverse Events
Timeframe: Up to Day 120
Number of Participants with Serious Adverse Events
Timeframe: Up to Day 120
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Timeframe: Up to Day 120
Sources for outcomes
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Healthy volunteers
- No
-
Male or female, of any race, between 18 and 60 years of age, inclusive.
a. Females must not be pregnant or lactating.
-
Body mass index between ≥25.0 and <40.0 kg/m^2.
- 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 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 or evidence of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity.
- 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.
- 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.
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
- 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.
- 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.
Sources for eligibility
- Anaheim Clinical TrialsAnaheim, United States
- Fortrea Clinical Research Unit - Daytona BeachDaytona Beach, United States
- Fortrea Clinical Research Unit - DallasDallas, United States
- Fortrea Clinical Research Unit Inc. - MadisonMadison, United States
Sources for sites
- Related resource (www.amgentrials.com)
Sources for references