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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06143956

Collaborator

(none)

165

Enrollment

Locations

Arm

17.9

Anticipated Duration (Months)

5.9

Patients Per Site

0.3

Patients Per Site Per Month

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
Obesity Overweight	Drug: LY3305677 Drug: Placebo	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:

Interventional

Anticipated Enrollment :

165 participants

Allocation:

N/A

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.

Masking:

None (Open Label)

Primary Purpose:

Screening

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.

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

Number of Participants Allocated to Each ISA [Baseline to Week 48]
Each ISA will detail the intervention specific analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

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

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

Investigators

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

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT06143956

Other Study ID Numbers:

18685
W8M-MC-CWMM

First Posted:

Nov 22, 2023

Last Update Posted:

Nov 22, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Overweight

Study Results

No Results Posted as of Nov 22, 2023