A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes

Part of paid clinical trials in Cypress, California.

Sponsor
Pfizer
Study ID
NCT06924320
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Obesity and Obesity-related Medical Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • MET233 and MET097 — DRUG
    For subcutaneous administration
  • Placebo — OTHER
    Sterile 0.9% (w/v) saline for subcutaneous administration.
  • MET097 — DRUG
    For subcutaneous administration

Study Details

This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.

Key Dates

Start date
Mar 6, 2025
Status verified
May 2026
Primary completion
Sep 15, 2026
Completion
Sep 15, 2026

Study Design

Enrollment
381 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Cohort
    Cohort participants will receive single co-administered ascending dose (SAD) of subcutaneous (SC) MET233 and SC MET097 or matched SC placebo.
  • Experimental: Part B Cohort
    Cohort Participants will receive multiple ascending dose (MAD) of co-administered SC MET233 with SC MET097 or matched SC placebo.
  • Experimental: Part C Cohort
    Cohort Participants will receive multiple doses of SC MET233 co-administered with SC MET097 or matched SC placebo in participants with T2DM.
  • Experimental: Part D Cohort
    Cohort Participants will receive multiple doses of weekly and monthly (ie, every 4 weeks \[QM\]) co-administered SC MET233 with SC MET097, or matched SC placebo in participants with obesity.
  • Experimental: Part E Cohort
    Cohort Participants will receive multiple dose QW-to-QM of SC MET233 co-administered with SC MET097 or matched SC placebo in participants with obesity.
  • Experimental: Part G Cohort
    Cohort Participants will receive multiple dose cohort of QW and QM SC MET097 monotherapy or matched SC placebo in participants with obesity or overweight.

Primary Outcome Measure

Occurrence of treatment-emergent adverse events (TEAEs) [ Time Frame: Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Altasciences Clinical Los Angeles, Inc.CypressCalifornia90630-

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Altasciences Clinical Los Angeles, Inc.· Cypress, CA

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