ObesityPhase 2NCT06230523
A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
A Phase 2 study testing Eloralintide in people with Obesity and Overweight, run by Eli Lilly and Company at 43 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Eloralintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 43 sitesUnited States
- Study dates
- 5 Feb 2024to 14 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
- Have a lifetime history of suicide attempts.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Dent Neurologic Institute
Amherst, New York, 14226
Medical Research Partners
Ammon, Idaho, 83406
IMA Clinical Research Austin
Austin, Texas, 78745
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, 85225
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640
CTI Clinical Research Center
Cincinnati, Ohio, 45212
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
FutureSearch Trials of Dallas
Dallas, Texas, 75251
Spectrum Medical, Inc.
Danville, Virginia, 24541
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057
Northeast Research Institute (NERI)
Fleming Island, Florida, 32003
NorCal Medical Research, Inc
Greenbrae, California, 94904
Medication Management
Greensboro, North Carolina, 27405
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96817
PlanIt Research, PLLC
Houston, Texas, 77079
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255
Las Vegas Medical Research
Las Vegas, Nevada, 89128
L-MARC Research Center
Louisville, Kentucky, 40213
Monroe Biomedical Research
Monroe, North Carolina, 28112
Quality Medical Research
Nashville, Tennessee, 37211
Knownwell
Needham, Massachusetts, 02492
Lucida Clinical Trials
New Bedford, Massachusetts, 02740
Lucas Research, Inc.
New Bern, North Carolina, 28562
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Charter Research - Winter Park
Orlando, Florida, 32803
North Suffolk Neurology
Port Jefferson Station, New York, 11776
Rochester Clinical Research, LLC
Rochester, New York, 14609
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Tekton Research - Fredericksburg Road
San Antonio, Texas, 78229
Endeavor Clinical Trials
San Antonio, Texas, 78240
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260
NorthShore University Health System
Skokie, Illinois, 60077
Headlands Research - Detroit
Southfield, Michigan, 48034
Charter Research - Lady Lake
The Villages, Florida, 32162
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, 85712
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
About this study
Official title: A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
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.
- Conditions
- Obesity, Overweight
- Being tested
- Eloralintide, Placebo
- Keywords
- Overnutrition, Hormones, Chronic weight management
- Medical subject headings
- Obesity, Overweight, Overnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EloralintideDrug
Also called LY3841136
Administered SC.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received subcutaneous (SC) injections of eloralintide-matching placebo administered once weekly (QW) for 48 weeks. Receives: Drug: Placebo |
| 1 mg Eloralintide | Experimental | Participants received eloralintide 1 milligram (mg) SC QW for 48 weeks. Receives: Drug: Eloralintide |
| 3 mg Eloralintide | Experimental | Participants received eloralintide 3 mg SC QW for 48 weeks. Receives: Drug: Eloralintide |
| 6 mg Eloralintide | Experimental | Participants received eloralintide 6 mg SC QW for 48 weeks. Receives: Drug: Eloralintide |
| 9 mg Eloralintide | Experimental | Participants received eloralintide 9 mg SC QW for 48 weeks. Receives: Drug: Eloralintide |
| 6/9 mg Eloralintide | Experimental | Participants 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. Receives: Drug: Eloralintide |
| 3/6/9 mg Eloralintide | Experimental | Participants 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. Receives: Drug: Eloralintide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 48
Secondary outcomes (6)
Change From Baseline in Body Weight at Week 48
LS means were calculated using a 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 (Change from Baseline) = Unstructured.
Measured: Baseline, Week 48
Mean Percentage of Participants Who Achieved Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline to Week 48
Mean percentage of participants who achieved ≥5% body weight reduction was analysed by logistic regression model with multiple imputation. Model: Variable = Baseline + Treatment + Sex + Baseline BMI Category. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 48 in imputed data sets using Rubin's rule.
Measured: Baseline to Week 48
Mean Percentage of Participants Who Achieved ≥ 10% Body Weight Reduction From Baseline to Week 48
Mean percentage of participants who achieved ≥10% body weight reduction was analysed by logistic regression model with multiple imputation. Model: Variable = Baseline + Treatment + Sex + Baseline BMI Category. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 48 in imputed data sets using Rubin's rule.
Measured: Baseline to Week 48
Change From Baseline in Body Mass Index (BMI) at Week 48
LS means were calculated using a 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 (Change from Baseline) = Unstructured.
Measured: Baseline, Week 48
Pharmacokinetics (PK): Area Under the Curve (AUC) of Eloralintide at Steady State
PK samples were analyzed using a population PK model approach to estimate AUC at steady state. Data presented are Geometric Mean with 90% prediction interval (PI).
Measured: 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
PK: Maximum Concentration (Cmax) of Eloralintide at Steady State
PK samples were analyzed using a population PK model approach to estimate Cmax at steady state. Data presented are Geometric Mean with 90% prediction interval (PI).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start5 Feb 2024
- Primary completion30 May 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230523
- Sponsor's protocol ID
- 18808
- Other IDs
- W8M-MC-LAA1, CWMM Master Protocol
- Status last verified
- May 2026
- First submitted
- 21 Jan 2024
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41207310
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
- ClinicalTrials.gov ID
- NCT06230523
- Acronym / sponsor ID
- 18808
- Conditions
- Obesity, Overweight
- Keywords
- Overnutrition, Hormones, Chronic weight management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Posted 24 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received subcutaneous (SC) injections of eloralintide-matching placebo administered once weekly (QW) for 48 weeks. |
| 1 mg Eloralintide | Experimental | Drug: EloralintideParticipants received eloralintide 1 milligram (mg) SC QW for 48 weeks. |
| 3 mg Eloralintide | Experimental | Drug: EloralintideParticipants received eloralintide 3 mg SC QW for 48 weeks. |
| 6 mg Eloralintide | Experimental | Drug: EloralintideParticipants received eloralintide 6 mg SC QW for 48 weeks. |
| 9 mg Eloralintide | Experimental | Drug: EloralintideParticipants received eloralintide 9 mg SC QW for 48 weeks. |
| 6/9 mg Eloralintide | Experimental | Drug: EloralintideParticipants 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 | Experimental | Drug: EloralintideParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- W8M-MC-LAA1
- Are males and females who agree to abide by the reproductive and contraceptive requirements
- Have a body mass index (BMI)
- Have had a stable body weight for the 3 months prior to randomization (<5%) body weight gain and/or loss.
Key exclusion criteria (16 listed)
- 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:
- Have a history of acute or chronic pancreatitis.
- Have an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening and baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EloralintideAlso: LY3841136Administered SC. | Drug | 1 mg Eloralintide, 3 mg Eloralintide, 3/6/9 mg Eloralintide, 6 mg Eloralintide, 6/9 mg Eloralintide, 9 mg Eloralintide |
| PlaceboAdministered SC. | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Body Weight at Week 48
Time frame: Baseline, 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.
6 secondary outcomes
Change From Baseline in Body Weight at Week 48
Time frame: Baseline, Week 48
Mean Percentage of Participants Who Achieved Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline to Week 48
Time frame: Baseline to Week 48
Mean Percentage of Participants Who Achieved ≥ 10% Body Weight Reduction From Baseline to Week 48
Time frame: Baseline to Week 48
Change From Baseline in Body Mass Index (BMI) at Week 48
Time frame: Baseline, Week 48
Pharmacokinetics (PK): Area Under the Curve (AUC) of Eloralintide at Steady State
Time frame: 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
PK: Maximum Concentration (Cmax) of Eloralintide at Steady State
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41207310Billings 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.
- A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or OverweightLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eloralintide in people with Obesity and Overweight, run by Eli Lilly and Company at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Body Weight at Week 48 (time frame: Baseline, Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06230523, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.