A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

Conditions

• Obesity
• Overweight

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• LY3305677 — DRUG
  Administered SC. ISA specific interventions will be listed in the ISA.
• LY3841136 — DRUG
  Administered SC. ISA specific interventions will be listed in the ISA.
• Tirzepatide — DRUG
  Administered SC. ISA specific interventions will be listed in the ISA.
• LY3549492 — DRUG
  Administered orally. ISA specific interventions will be listed in the ISA.
• LY3532226 — DRUG
  Administered SC. ISA specific interventions will be listed in the ISA.
• Placebo — DRUG
  Administered SC. ISA specific interventions will be listed in the ISA.
• Placebo — DRUG
  Administered orally. ISA specific interventions will be listed in the ISA.

Study Details

The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.

Key Dates

Start date

Nov 17, 2023

Status verified

May 2026

Primary completion

Sep 30, 2027

Completion

Feb 29, 2028

Study Design

Enrollment

1,481 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: LY3305677 Obesity ISA OXA1
  Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis.
• Experimental: LY3841136 Obesity ISA LAA1
  Participants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis.
• Experimental: LY3841136 Obesity ISA LAA2
  Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis.
• Experimental: LY3549492 Obesity ISA GN01
  Participants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis.
• Experimental: LY3549492 Obesity ISA GN02
  Participants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis.
• Experimental: Obesity ISA MC01
  Participants will receive macupatide, eloralintide, and placebo SC. Each ISA will detail the intervention specific analysis.

Primary Outcome Measure

Number of Participants Allocated to Each ISA [ Time Frame: Baseline to Week 6 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (49)

Find similar trials in Chandler, AZ

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