Health TrialsbyHealthPanel

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

ConditionsObesityOverweight
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,481 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: LY3305677 Obesity ISA OXA1Experimental treatment 2 interventions
Group B: LY3841136 Obesity ISA LAA1Experimental treatment 2 interventions
Group C: LY3841136 Obesity ISA LAA2Experimental treatment 3 interventions
Group D: LY3549492 Obesity ISA GN01Experimental treatment 2 interventions
Group E: LY3549492 Obesity ISA GN02Experimental treatment 2 interventions
Group F: Obesity ISA MC01Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Allocated to Each ISA

Each ISA will detail the intervention specific analysis.

Time frame
Baseline to Week 6

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
Apply now