NCT07908316 · Amgen
Comparing the Extent to Which Maridebart Cafraglutide is Made Available in the Body of Participants Living With Overweight or Obesity After Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA)
What this study is about
The primary purpose of the study is to assess the how the drug moves through the body of maridebart cafraglutode after switching from weekly GLP-1RA in participants living with overweight or obesity.
View original scientific description
The primary purpose of the study is to assess the pharmacokinetics of maridebart cafraglutode after switching from weekly GLP-1RA in participants living with overweight or obesity.
Interventions
DRUG
Maridebart cafraglutide
Administered subcutaneously.
Primary outcome measures
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUCtau) of Maridebart Cafraglutide
Time frame: Up To 115 days
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Time frame: Up To 115 days
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 to 70 years of age.
- Body Mass Index (BMI) ≥ 25 at screening.
- BMI ≥ 23 for Asian participants at screening.
- Stable body weight (approximately 5% or less gain or loss) during the 4-week run-in period, unless the study doctor determines otherwise.
- Stable dose of weekly GLP-1RA.
- Stable gastrointestinal (GI) tolerability.
- Contraception for females.
- Stable for 3 months if obstructive sleep apnea (OSA), hypertension, hyperlipidemia, and/or hypothyroidism.
- Willingness to follow trial procedures for the duration of the trial.
Exclusion criteria
- Type 1/Type 2 diabetes mellitus (DM).
- Obesity induced by other endocrine disorder (ex: Cushing's syndrome).
- History of malignancy in the last 5 tears except for nonmelanoma skin cancers, cervical, or breast ductal carcinoma in situ.
- Acute \& chronic pancreatitis within 1 year.
- Uncontrolled thyroid disease.
- Gastroparesis or gastric outlet obstruction.
- Surgery for obesity in the last 6 months.
- Heart attack within 3 months.
- History of ischemic optic neuropathy.
- Positive HIV or certain positive Hepatitis B or hepatitis C.
- Current use of compounded weekly GLP-1RA.
- Previous participation in Maridebart cafraglutide trial.
- Alcohol or drug abuse.
- Pregnancy, breastfeeding, or planning to breastfeed.
Where
- Phoenix, Arizona
- Montclair, California
- Daytona Beach, Florida
- Hialeah, Florida
- Maitland, Florida
- Lexington, Kentucky
- Knoxville, Tennessee
- Dallas, Texas
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 2, 2026 · Source of record for eligibility and locations