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

Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

Study Description

Brief Summary

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 ISAs may start independently of other ISAs as interventions become available for clinical testing.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The results for the CWMM screening record will be reported when all the ISA's complete.

Study Design

Study Type:
Anticipated Enrollment :
165 participants
Intervention Model:
Single Group Assignment
Intervention Model Description:
The CWMM protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.The CWMM protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.
None (Open Label)
Primary Purpose:
Official Title:
A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight
Anticipated Study Start Date :
Nov 17, 2023
Anticipated Primary Completion Date :
Nov 29, 2024
Anticipated Study Completion Date :
May 16, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3305677 Obesity ISA OXA1

Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis.

Drug: LY3305677
Administered SC. ISA specific interventions will be listed in the ISA.

Drug: Placebo
Administered SC. ISA specific interventions will be listed in the ISA.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants Allocated to Each ISA [Baseline to Week 48]

    Each ISA will detail the intervention specific analysis.

Eligibility Criteria


Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Have a Body Mass Index (BMI) ≥30 kilograms per square meter (kg/m²)

  • Have a BMI ≥27 kg/m²and <30 kg/m² with at least one of the following weight-related comorbidities:

  • hypertension: on blood pressure (BP)-lowering medication.

  • dyslipidemia: on lipid-lowering medication

  • cardiovascular (CV) disease: for example, ischemic CV disease, New York Heart Association (NYHA) Functional Classification Class I or II heart failure.

  • obstructive sleep apnea

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

Exclusion Criteria:
  • 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.

  • Have any of the following cardiovascular conditions within 3 months prior to screening:

  • acute myocardial infarction

  • cerebrovascular accident (stroke)

  • unstable angina, or

  • hospitalization due to congestive heart failure.

  • Have a history of symptomatic gallbladder disease within the past 2 years.

  • Have a lifetime history of suicide attempts.

Contacts and Locations


Site City State Country Postal Code
1 The Institute for Liver Health dba Arizona Clinical Trials Mesa Arizona United States 85210
2 Headlands Research - Scottsdale Scottsdale Arizona United States 85260
3 The Institute for Liver Health II dba Arizona Liver Health-Tucson Tucson Arizona United States 85712
4 National Research Institute - Huntington Park Huntington Park California United States 90255
5 Peninsula Research Associates Rolling Hills Estates California United States 90274
6 Diablo Clinical Research, Inc. Walnut Creek California United States 94598
7 Northeast Research Institute (NERI) Fleming Island Florida United States 32003
8 Suncoast Clinical Research, Inc. New Port Richey Florida United States 34652
9 Charter Research - Lady Lake The Villages Florida United States 32162
10 Charter Research - Winter Park Winter Park Florida United States 32792
11 Pacific Diabetes & Endocrine Center Honolulu Hawaii United States 96813
12 Great Lakes Clinical Trials - Andersonville Chicago Illinois United States 60640
13 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
14 Cotton O'Neil Clinical Research Center Topeka Kansas United States 66606
15 L-MARC Research Center Louisville Kentucky United States 40213
16 Knownwell Needham Massachusetts United States 02492
17 Lucida Clinical Trials New Bedford Massachusetts United States 02740
18 Headlands Research - Detroit Southfield Michigan United States 48034
19 Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan United States 48098
20 Dent Neurologic Institute Amherst New York United States 14226
21 Clarity Clinical Research East Syracuse New York United States 13057
22 North Suffolk Neurology Port Jefferson Station New York United States 11776
23 Rochester Clinical Research, Inc. Rochester New York United States 14609
24 Monroe Biomedical Research Monroe North Carolina United States 28112
25 Lucas Research - New Bern New Bern North Carolina United States 28562
26 Quality Medical Research Nashville Tennessee United States 37211
27 Dallas Diabetes Research Center Dallas Texas United States 75230
28 Tekton Research - Fredericksburg Road San Antonio Texas United States 78229

Sponsors and Collaborators

  • Eli Lilly and Company


  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4550 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST, Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 18685
First Posted:
Nov 22, 2023
Last Update Posted:
Nov 22, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2023