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| ID | Type | Description | Link |
|---|---|---|---|
| J3R-MC-YDAF | Other Identifier | Eli Lilly and Company | |
| 2025-523658-15-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eloralintide Dose 1 | Experimental | Participants will receive eloralintide subcutaneously (SC) |
|
| Eloralintide Dose 2 | Experimental | Participants will receive eloralintide SC |
|
| Eloralintide Dose 3 | Experimental | Participants will receive eloralintide SC |
|
| Eloralintide Dose 4 | Experimental | Participants will receive eloralintide SC |
|
| Placebo | Placebo Comparator | Participants will receive placebo SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eloralintide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Total Body Fat Mass | Baseline, Week 64 | |
| Change from Baseline in Waist Circumference | Baseline, Week 64 | |
| Change from Baseline in Hemoglobin A1c (HbA1c) |
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Inclusion Criteria:
Exclusion Criteria:
Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >1 year before screening)
Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
Have type 1 diabetes
Have taken any of the following antihyperglycemic medications within 90 days before screening:
Have had within 90 days prior to screening:
Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
Have taken medications or alternative remedies intended for weight loss within 90 days of screening
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Clinical Research | Recruiting | Birmingham | Alabama | 35209 | United States |
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| Label | URL |
|---|---|
| A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes (ENLIGHTEN-2) | View source |
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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.
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo | Drug | Administered SC |
|
| Baseline, Week 64 |
| Percent Change in Baseline in Triglycerides | Baseline, Week 64 |
| Change from Baseline in Systolic Blood Pressure | Baseline, Week 64 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 64 |
| Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP) | Baseline, Week 64 |
| Percent Change from Baseline in Fasting Insulin | Baseline, Week 64 |
| Change in Medication Use | Baseline through Week 64 |
| Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) | Baseline, Week 64 |
| Change from Baseline in Short Form-36 (SF-36 v2) Score | Baseline, Week 64 |
| Change from Baseline in EQ-5D-5L Score | Baseline, Week 64 |
| Change from Baseline in Control of Eating Questionnaire (CoEQ) Score | Baseline, Week 64 |
| Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight | Baseline, Week 64 |
| Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss) | Baseline through Week 64 |
| PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss) | Baseline through Week 64 |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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