A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
3 other identifiers
interventional
263
1 country
43
Brief Summary
The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3841136 compared with placebo in adult participants with obesity or overweight. The study will last about 64 weeks and may include up to 17 visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Feb 2024
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2024
CompletedFirst Posted
Study publicly available on registry
January 30, 2024
CompletedStudy Start
First participant enrolled
February 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2025
CompletedResults Posted
Study results publicly available
June 24, 2026
CompletedJune 24, 2026
May 1, 2026
1.3 years
January 21, 2024
May 28, 2026
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Body Weight at Week 48
Least squares (LS) means were calculated using a mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time\*Sex +Time\*Baseline BMI Category + Treatment\*Time + Time\*Baseline. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Baseline, Week 48
Secondary Outcomes (6)
Change From Baseline in Body Weight at Week 48
Baseline, Week 48
Mean Percentage of Participants Who Achieved Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline to Week 48
Baseline to Week 48
Mean Percentage of Participants Who Achieved ≥ 10% Body Weight Reduction From Baseline to Week 48
Baseline to Week 48
Change From Baseline in Body Mass Index (BMI) at Week 48
Baseline, Week 48
Pharmacokinetics (PK): Area Under the Curve (AUC) of Eloralintide at Steady State
Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 36; Post dose (2 to 6 hours after dosing) at Week 0, Week 24; Post dose (24 to 72 hours after dosing) at Week 12; random at Week 48
- +1 more secondary outcomes
Study Arms (7)
Placebo
PLACEBO COMPARATORParticipants received subcutaneous (SC) injections of eloralintide-matching placebo administered once weekly (QW) for 48 weeks.
1 mg Eloralintide
EXPERIMENTALParticipants received eloralintide 1 milligram (mg) SC QW for 48 weeks.
3 mg Eloralintide
EXPERIMENTALParticipants received eloralintide 3 mg SC QW for 48 weeks.
6 mg Eloralintide
EXPERIMENTALParticipants received eloralintide 6 mg SC QW for 48 weeks.
9 mg Eloralintide
EXPERIMENTALParticipants received eloralintide 9 mg SC QW for 48 weeks.
6/9 mg Eloralintide
EXPERIMENTALParticipants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
3/6/9 mg Eloralintide
EXPERIMENTALParticipants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
Interventions
Administered SC.
Eligibility Criteria
You may qualify if:
- W8M-MC-LAA1
- Are males and females who agree to abide by the reproductive and contraceptive requirements
- W8M-MC-CWMM:
- 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.
You may not qualify if:
- W8M-MC-LAA1
- Have any prior diagnosis 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 an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening and baseline.
- 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 a history of symptomatic gallbladder disease within the past 2 years
- Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, 85225, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, 85712, United States
NorCal Medical Research, Inc
Greenbrae, California, 94904, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, 32003, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Charter Research - Winter Park
Orlando, Florida, 32803, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96817, United States
Medical Research Partners
Ammon, Idaho, 83406, United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640, United States
NorthShore University Health System
Skokie, Illinois, 60077, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Knownwell
Needham, Massachusetts, 02492, United States
Lucida Clinical Trials
New Bedford, Massachusetts, 02740, United States
Headlands Research - Detroit
Southfield, Michigan, 48034, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057, United States
North Suffolk Neurology
Port Jefferson Station, New York, 11776, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Medication Management
Greensboro, North Carolina, 27405, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Lucas Research, Inc.
New Bern, North Carolina, 28562, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Quality Medical Research
Nashville, Tennessee, 37211, United States
IMA Clinical Research Austin
Austin, Texas, 78745, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75251, United States
PlanIt Research, PLLC
Houston, Texas, 77079, United States
Tekton Research - Fredericksburg Road
San Antonio, Texas, 78229, United States
Endeavor Clinical Trials
San Antonio, Texas, 78240, United States
Spectrum Medical, Inc.
Danville, Virginia, 24541, United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801, United States
Related Publications (1)
Billings LK, Hsia S, Bays H, Tidemann-Miller B, O'Hagan J, Tham LS, Butler A, Kazda C, Mather KJ, Coskun T. Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2025 Dec 6;406(10520):2631-2643. doi: 10.1016/S0140-6736(25)02155-5. Epub 2025 Nov 6.
PMID: 41207310DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2024
First Posted
January 30, 2024
Study Start
February 5, 2024
Primary Completion
May 30, 2025
Study Completion
August 14, 2025
Last Updated
June 24, 2026
Results First Posted
June 24, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.