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Recruiting
Sponsor ID
20250233

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)

Sponsor ID
20250233
Clinicaltrials.gov ID
NCT07908316
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 133
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
180
Additional Study Details

Protocol Summary

Primary Outcome Measures

Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUCtau) of Maridebart Cafraglutide

Timeframe: Up To 115 days

Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide

Timeframe: Up To 115 days

Secondary Outcome Measures

Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: TEAEs: From baseline (Day 1) up to end of trial (approximately 16 weeks). SAEs: From screening (Day -56) up to end of trial (approximately 24 weeks).

Number of Participants Who Develop Anti-Maridebart Cafraglutide Antibodies

Timeframe: Up To 115 days

Locations

Location
Status
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Location
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, FL, United States, 32117-5116
Status
Recruiting
Location
Fortrea Clinical Research Unit - Dallas
Dallas, TX, United States, 75247-4968
Status
Recruiting
Location
Fortrea Clinical Research Unit Inc. - Madison
Madison, WI, United States, 53704-2526
Status
Recruiting
Location
Alliance for Multispecialty Research - Knoxville
Knoxville, TN, United States, 37920-1534
Status
Recruiting
Location
Catalina Research Institute LLC (CRI) - Montclair
Montclair, CA, United States, 91763
Status
Recruiting
Location
Arizona Research Center
Phoenix, AZ, United States, 85053
Status
Recruiting
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Study Info
Age
18 - 70 Years
Condition
  • Weight Loss & Obesity
    • Sex
    All
    Trial Dates
    Nov 2026 - Dec 2027
    Inclusion and Exclusion Criteria
    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.