Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight

Sponsor
Hudson Biotech
Study ID
NCT07467447
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Retatrutide (LY3437943) — DRUG
    subcutaneous injection, once weekly (dose per assigned arm).
  • Placebo — DRUG
    subcutaneous injection, once weekly (schedule matched to an active arm).
  • Standardized diet and physical activity counseling throughout the study. — BEHAVIORAL
    Standardized diet and physical activity counseling throughout the study.

Study Details

Phase 2, multicenter, randomized, double-blind, placebo-controlled study evaluating once-weekly subcutaneous retatrutide (LY3437943) at multiple maintenance dose levels versus placebo in adults with obesity or overweight with weight-related comorbidities (without type 2 diabetes), alongside standardized diet and physical activity counseling.

Key Dates

Start date
Feb 15, 2026
Status verified
Mar 2026
Primary completion
Mar 14, 2027
Completion
Feb 17, 2028

Study Design

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

Arms

  • Experimental: Retatrutide (LY3437943) 1 mg once weekly (no escalation)
  • Experimental: Retatrutide 4 mg once weekly, escalation subgroup (a): 2 mg → 4 mg.
  • Experimental: Retatrutide 4 mg once weekly, subgroup (b): start 4 mg (no escalation).
  • Experimental: Retatrutide 8 mg once weekly, subgroup (a): 2 mg → 4 mg → 8 mg
  • Experimental: Retatrutide 12 mg once weekly: 2 mg → 4 mg → 8 mg → 12 mg.
  • Experimental: Placebo once weekly (matched escalation schedule to maintain blinding).
  • Experimental: Retatrutide 8 mg once weekly, subgroup (b): 4 mg → 8 mg.

Primary Outcome Measure

Mean percent change in body weight from randomization/baseline to Week 24. [ Time Frame: 24 weeks ]

Central Contacts

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