Comparing the Extent to Which Two Maridebart Cafraglutide Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
NCT07832799
Phase
Phase 1
Recruitment status
Not yet recruiting
Participants
Lead sponsor
Amgen
Start date
2026-10-12
- Summary
- The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two maridebart cafraglutide drug products in participants living with overweight or obesity.
- Short title
- Comparing the Extent to Which Two Maridebart Cafraglutide Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
- Official title
- A Phase 1, Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Two Maridebart Cafraglutide (AMG 133) Drug Products in Participants Living With Overweight or Obesity
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-03-23
- First posted
- 2026-09-22
- Registry last updated
- 2026-09-22
- Primary completion date
- 2027-03-23
- Start date
- 2026-10-12
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Amgen
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07832799
- ClinicalTrials.gov ID
- NCT07832799
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide
Timeframe: Up to Day 120
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Maridebart Cafraglutide
Timeframe: Up to Day 120
Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide
Timeframe: Up to Day 120
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Timeframe: Up to Day 120
Number of Participants With Anti-Maridebart Cafraglutide Antibodies
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 participants, of any race, between 18 and 60 years of age (inclusive).
- Females must not be pregnant or lactating.
- Body mass index of ≥ 25.0 to < 40.0 kilograms per square meter (kg/m^2).
- Have a stable body weight within 3 months before screening.
- History or evidence 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, except history of gestational diabetes), or hemoglobin A1c ≥ 6.5%.
- History or evidence of endocrine disorder that can cause obesity.
- History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase or amylase (> 2 x upper limit of normal [ULN]) at screening or check-in, or fasting serum triglyceride level of > 500 milligrams per deciliter (mg/dL) at screening.
- Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ treated with curative intent, within the last 5 years.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2.
- History or current signs or symptoms of cardiovascular disease.
- History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or its ingredients.
- Estimated glomerular filtration rate ≤ 60 mL/min/1.73 m^2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (2021) 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, 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, vitamins, and supplements consumed by the participant within the 30 days prior to check-in.
- 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 maridebart cafraglutide.
Sources for eligibility
- Related resource (www.amgentrials.com)
Sources for references