RecruitingPhase 1

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)

A Phase 1, Randomized, Double-blind, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Maridebart Cafraglutide After Switching From Glucagon-like Peptide-1 Receptor Agonists in Participants Living With Overweight or Obesity

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

Recruiting sites

Estimated enrollment

180

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥25

Primary endpoints

•AUC Over a Dosing Interval (AUCtau) of Maridebart Cafraglutide•Cmax of Maridebart Cafraglutide

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07908316

Org study ID20250233

Timeline

Milestones

Study first posted2026-11-02actual

Last update posted2026-11-02actual

Study start2026-11-13estimated

Primary completion2027-12-20estimated

Study completion2028-02-25estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other clinical outcomes

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

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

Time frame:Up To 115 days

concentration, descriptive

Primary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide

Time frame:Up To 115 days

concentration, descriptive

Secondary/protocol endpoint

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

Time frame: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).

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Number of Participants Who Develop Anti-Maridebart Cafraglutide Antibodies

Time frame:Up To 115 days

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.