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A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06124807
Collaborator
(none)
165
Enrollment
24
Locations
4
Arms
17.9
Anticipated Duration (Months)
6.9
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study, performed under a master protocol, is to investigate weight management efficacy and safety with LY3305677 compared with placebo and in adult participants with obesity or overweight. The study will last about 62 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Parallel-Group, Double-Blind, 4-Arm Study to Investigate Weight Management With LY3305677 Compared With Placebo and 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 Dose 1

Participants will receive LY3305677 subcutaneously (SC).

Drug: LY3305677
Administered SC
Experimental: LY3305677 Dose 2

Participants will receive LY3305677 SC.

Drug: LY3305677
Administered SC
Experimental: LY3305677 Dose 3

Participants will receive LY3305677 SC.

Drug: LY3305677
Administered SC
Placebo Comparator: Placebo

Participants will receive LY3305677 matching placebo.

Drug: Placebo
Administered SC

Outcome Measures

Primary Outcome Measures

  1. Percent Change from Baseline in Body Weight [Baseline, Week 32]

Secondary Outcome Measures

  1. Percent Change from Baseline in Body Weight [Baseline, Week 48]

  2. Change from Baseline in Body Weight [Baseline, Week 32]

  3. Change from Baseline in Body Weight [Baseline, Week 48]

  4. Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Baseline to Week 32]

  5. Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Baseline to Week 48]

  6. Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Baseline to Week 32]

  7. Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Baseline to Week 48]

  8. Change from Baseline in Body Mass Index (BMI) [Baseline, Week 48]

  9. Change from Baseline in BMI [Baseline, Week 32]

  10. Absolute Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) [Baseline, Week 32]

  11. Percent Change from Baseline in Liver Fat Content by MRI-PDFF [Baseline, Week 32]

  12. Absolute Change from Baseline in Liver Fat Content by MRI-PDFF [Baseline, Week 48]

  13. Percent Change from Baseline in Liver Fat Content by MRI-PDFF [Baseline, Week 48]

  14. Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3305677 [Baseline to Week 48]

  15. PK: Maximum Concentration (Cmax) of LY3305677 [Baseline to Week 48]

  16. Number of Participants with Treatment Emergent Drug Antibodies (TE-ADAs) [Baseline to Week 56]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
W8M-MC-OXA1:
  • Are males and females who agree to abide by the reproductive and contraceptive requirements
W8M-MC-CWMM:

  • Have a BMI ≥27 kilograms per square meter (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 1 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:
W8M-MC-OXA1:

  • Have any prior diagnosis of diabetes mellitus, that is type 2 diabetes mellitus (T2DM), or rare forms of diabetes mellitus, except gestational diabetes.

  • Have any of the following cardiovascular conditions within 6 months prior to screening:

  • acute myocardial infarction

  • cerebrovascular accident (stroke)

  • unstable angina, or

  • hospitalization due to congestive heart failure (CHF).

  • Have a history of acute or chronic pancreatitis.

  • Have a history of New York Heart Association (NYHA) Functional Classification I IV CHF.

  • Participants with hypertension who do not have well-controlled blood pressure (BP) (>140/90 mmHg), regardless of antihypertensive treatment. Participants receiving treatment for hypertension should be on a stable antihypertensive regimen for at least 3 months prior to screening.

Note: If the investigator anticipates a need to add antihypertensive medication during the study, the participant should not be included in the ambulatory blood pressure monitoring (ABPM) procedures.

W8M-MC-CWMM:

  • 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 Cotton O'Neil Clinical Research Center Topeka Kansas United States 66606
14 L-MARC Research Center Louisville Kentucky United States 40213
15 Knownwell Needham Massachusetts United States 02492
16 Headlands Research - Detroit Southfield Michigan United States 48034
17 Dent Neurologic Institute Amherst New York United States 14226
18 Clarity Clinical Research East Syracuse New York United States 13057
19 North Suffolk Neurology Port Jefferson Station New York United States 11776
20 Rochester Clinical Research, Inc. Rochester New York United States 14609
21 Lucas Research - New Bern New Bern North Carolina United States 28562
22 Quality Medical Research Nashville Tennessee United States 37211
23 Dallas Diabetes Research Center Dallas Texas United States 75230
24 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 1-317-615-4559 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:
NCT06124807
Other Study ID Numbers:
  • 18661
  • W8M-MC-OXA1
  • CWMM Master Protocol
  • 2022-502816-35-00
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 9, 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:
No
Keywords provided by Eli Lilly and Company
Incretins
Weight Loss
Overnutrition
Additional relevant MeSH terms:
Obesity
Overweight

Study Results

No Results Posted as of Nov 9, 2023