A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus

Part of paid clinical trials in Chula Vista, California.

Sponsor
Amgen
Study ID
NCT07160257
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Maridebart cafraglutide — DRUG
    Maridebart cafraglutide will be administered SC.
  • Placebo — DRUG
    Placebo will be administered SC.

Study Details

The primary objective of this study is to determine the effect of maridebart cafraglutide relative to placebo on insulin sensitivity in participants with Type 2 Diabetes Mellitus (T2DM) treated with stable dose of metformin.

Key Dates

Start date
Aug 5, 2025
Status verified
May 2026
Primary completion
Nov 2, 2026
Completion
Feb 19, 2027

Study Design

Enrollment
57 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Maridebart cafraglutide
    Participants will receive maridebart cafraglutide subcutaneously (SC).
  • Placebo Comparator: Placebo
    Participants will receive placebo SC.

Primary Outcome Measure

Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25 [ Time Frame: Baseline and Week 25 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ProSciento, Inc. - Main ClinicChula VistaCalifornia91911-1350-

Find similar trials in Chula Vista, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
ProSciento, Inc. - Main Clinic· Chula Vista, CA

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