A Phase 2 interventional study of Eloralintide and Placebo in Obesity and Overweight, sponsored by Eli Lilly and Company. Completed at 43 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 263 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
W8M-MC-LAA1
W8M-MC-CWMM:
Have a (BMI)
Exclusion Criteria:
W8M-MC-LAA1
Have any of the following cardiovascular conditions within 6 months prior to screening:
W8M-MC-CWMM
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received subcutaneous (SC) injections of eloralintide-matching placebo administered once weekly (QW) for 48 weeks.
Drug: Placebo
Participants received eloralintide 1 milligram (mg) SC QW for 48 weeks.
Drug: Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
Drug: Eloralintide
Participants received eloralintide 6 mg SC QW for 48 weeks.
Drug: Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks.
Drug: Eloralintide
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.
Drug: Eloralintide
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.
Drug: Eloralintide
Administered SC.
Also known as: LY3841136
Administered SC.
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.
Time frame: Baseline, Week 48
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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
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).
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
| Milestone | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide |
|---|---|---|---|---|---|---|---|
| Started | 53 | 28 | 24 | 28 | 54 | 24 | 52 |
| Completed | 38 | 15 | 19 | 21 | 48 | 19 | 46 |
| Not completed | 15 | 13 | 5 | 7 | 6 | 5 | 6 |
| Withdrew: Adverse event | 2 | 2 | 0 | 1 | 1 | 0 | 2 |
| Withdrew: Lost to follow-up | 5 | 3 | 2 | 3 | 2 | 2 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 6 | 7 | 2 | 3 | 2 | 3 | 3 |
| Withdrew: Other | 1 | 1 | 1 | 0 | 1 | 0 | 1 |
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.
| percent change | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide |
|---|---|---|---|---|---|---|---|
| Percent Change From Baseline in Body Weight at Week 48 | -0.4 ± 0.91 | -9.4 ± 1.60 | -12.4 ± 1.30 | -17.6 ± 1.56 | -20.1 ± 1.31 | -19.9 ± 1.45 | -16.5 ± 1.18 |
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.
| Kilograms (Kg) | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Body Weight at Week 48 | -0.2 ± 1.01 | -10.2 ± 1.66 | -13.3 ± 1.37 | -18.7 ± 1.81 | -21.3 ± 1.41 | -21.0 ± 1.46 | -18.0 ± 1.37 |
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.
| percentage of participants | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide |
|---|---|---|---|---|---|---|---|
| Mean Percentage of Participants Who Achieved Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline to Week 48 | 31.21 ± 7.19 | 71.55 ± 9.81 | 87.12 ± 7.75 | 84.99 ± 8.04 | 92.72 ± 4.07 | 97.50 ± 4.00 | 90.80 ± 4.78 |
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.
| percentage of participants | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide |
|---|---|---|---|---|---|---|---|
| Mean Percentage of Participants Who Achieved ≥ 10% Body Weight Reduction From Baseline to Week 48 | 12.85 ± 5.37 | 53.25 ± 10.76 | 60.45 ± 11.06 | 76.57 ± 9.27 | 82.32 ± 5.55 | 91.13 ± 6.33 | 79.24 ± 6.17 |
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.
| kilogram per square metre (kg/m^2) | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Body Mass Index (BMI) at Week 48 | -0.2 ± 0.37 | -3.7 ± 0.58 | -4.7 ± 0.50 | -6.7 ± 0.65 | -7.7 ± 0.50 | -7.8 ± 0.60 | -6.4 ± 0.47 |
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).
| nanogram*hour per milliliter (ng*h/mL) | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide |
|---|---|---|---|---|
| Pharmacokinetics (PK): Area Under the Curve (AUC) of Eloralintide at Steady State | 47300 (NA to NA) | 148000 (NA to NA) | 306000 (NA to NA) | 468000 (NA to NA) |
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).
| nanogram per milliliter (ng/mL) | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide |
|---|---|---|---|---|
| PK: Maximum Concentration (Cmax) of Eloralintide at Steady State | 322 (NA to NA) | 1010 (NA to NA) | 2090 (NA to NA) | 3210 (NA to NA) |
Collected over Baseline to end of safety follow-up (up to 58 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/53 (0%) | 3/53 (5.7%) | 25/53 (47.2%) |
| 1 mg Eloralintide | 0/28 (0%) | 3/28 (10.7%) | 15/28 (53.6%) |
| 3 mg Eloralintide | 0/24 (0%) | 1/24 (4.2%) | 12/24 (50%) |
| 6 mg Eloralintide | 0/28 (0%) | 1/28 (3.6%) | 27/28 (96.4%) |
| 9 mg Eloralintide | 0/54 (0%) | 3/54 (5.6%) | 40/54 (74.1%) |
| 6/9 mg Eloralintide | 0/24 (0%) | 2/24 (8.3%) | 20/24 (83.3%) |
| 3/6/9 mg Eloralintide | 0/52 (0%) | 1/52 (1.9%) | 34/52 (65.4%) |
| Event | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide |
|---|---|---|---|---|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/40 | 1/21 | 0/19 | 0/21 | 0/43 | 0/19 | 0/41 |
| Acute myocardial infarctionCardiac disorders | 0/53 | 0/28 | 1/24 | 0/28 | 0/54 | 1/24 | 0/52 |
| Spondylitic myelopathyNervous system disorders | 0/53 | 0/28 | 0/24 | 0/28 | 0/54 | 1/24 | 0/52 |
| LymphadenopathyBlood and lymphatic system disorders | 0/53 | 1/28 | 0/24 | 0/28 | 0/54 | 0/24 | 0/52 |
| Atrial flutterCardiac disorders | 0/53 | 1/28 | 0/24 | 0/28 | 0/54 | 0/24 | 0/52 |
| Multiple sclerosisNervous system disorders | 0/53 | 0/28 | 0/24 | 1/28 | 0/54 | 0/24 | 0/52 |
| Suicidal ideationPsychiatric disorders | 0/53 | 1/28 | 0/24 | 0/28 | 0/54 | 0/24 | 0/52 |
| Diverticulitis meckel'sCongenital, familial and genetic disorders | 0/53 | 0/28 | 0/24 | 0/28 | 0/54 | 0/24 | 1/52 |
| Small intestinal obstructionGastrointestinal disorders | 0/53 | 0/28 | 0/24 | 0/28 | 0/54 | 0/24 | 1/52 |
| MastoiditisInfections and infestations | 1/53 | 0/28 | 0/24 | 0/28 | 0/54 | 0/24 | 0/52 |
| Event | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide |
|---|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 7/53 | 3/28 | 3/24 | 18/28 | 18/54 | 13/24 | 13/52 |
| FatigueGeneral disorders | 6/53 | 0/28 | 3/24 | 8/28 | 23/54 | 11/24 | 11/52 |
| DiarrhoeaGastrointestinal disorders | 5/53 | 1/28 | 2/24 | 10/28 | 6/54 | 3/24 | 9/52 |
| VomitingGastrointestinal disorders | 0/53 | 0/28 | 0/24 | 7/28 | 6/54 | 4/24 | 1/52 |
| ConstipationGastrointestinal disorders | 3/53 | 4/28 | 4/24 | 2/28 | 13/54 | 4/24 | 4/52 |
| Upper respiratory tract infectionInfections and infestations | 6/53 | 2/28 | 2/24 | 2/28 | 0/54 | 5/24 | 3/52 |
| Benign prostatic hyperplasiaReproductive system and breast disorders | 2/13 | 1/7 | 0/5 | 0/7 | 0/11 | 0/5 | 0/11 |
| Decreased appetiteMetabolism and nutrition disorders | 2/53 | 0/28 | 2/24 | 4/28 | 8/54 | 1/24 | 5/52 |
| Covid-19Infections and infestations | 2/53 | 4/28 | 1/24 | 3/28 | 0/54 | 2/24 | 5/52 |
| Prostate infectionInfections and infestations | 0/13 | 0/7 | 0/5 | 1/7 | 0/11 | 0/5 | 0/11 |
All randomized participants.
| Age, Continuous(years) | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 48.80 ± 12.30 | 50.40 ± 13.93 | 48.60 ± 12.17 | 46.10 ± 14.57 | 50.20 ± 12.34 | 49.10 ± 10.93 | 48.70 ± 12.89 | 49.00 ± 12.65 |
| Sex: Female, Male(Participants) | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 40 | 21 | 19 | 21 | 43 | 19 | 41 | 204 |
| Male | 13 | 7 | 5 | 7 | 11 | 5 | 11 | 59 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 10 | 3 | 1 | 1 | 10 | 6 | 10 | 41 |
| Not Hispanic or Latino | 43 | 25 | 23 | 27 | 44 | 18 | 42 | 222 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 2 |
| Asian | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 3 |
| Black or African American | 10 | 5 | 4 | 3 | 14 | 2 | 10 | 48 |
| White | 41 | 21 | 19 | 24 | 39 | 22 | 39 | 205 |
| More than one race | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Region of Enrollment(Participants) | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide | Total |
|---|---|---|---|---|---|---|---|---|
| United States | 53 | 28 | 24 | 28 | 54 | 24 | 52 | 263 |
| Body Weight(Kilograms (Kg)) | Placebo | 1 mg Eloralintide | 3 mg Eloralintide | 6 mg Eloralintide | 9 mg Eloralintide | 6/9 mg Eloralintide | 3/6/9 mg Eloralintide | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 109.02 ± 21.96 | 113.02 ± 34.96 | 107.75 ± 18.97 | 106.94 ± 18.15 | 106.99 ± 17.17 | 110.03 ± 24.55 | 110.76 ± 24.18 | 109.13 ± 22.75 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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.
Data sharing details ↗ · vivli.org
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Eloralintide