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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

Qualifiers

Have a body mass index (BMI)

≥30 kilogram/square meter (kg/m²), or

≥27 kg/m² and <30 kg/m², or with at least 1 weight-related comorbidity

Have had a stable body weight for the 3 months prior to randomization (<5%) body weight gain and/or loss.

Disqualifiers

Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening.

Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.

Have poorly controlled hypertension.

Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.

Trial design

Treatments tested in this trial

  • LY3305677
  • LY3841136
  • Tirzepatide
  • LY3549492
  • LY3532226
  • Placebo
  • Placebo

Treatment groups

1,481 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators