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> Record changed: 2026-10-13

# A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes

NCT07321886

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

Participants

1,980

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

Lead sponsor

Eli Lilly and Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

Start date

2026-02-06

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

Number of sites

162

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

## Title and summary

**Summary**

The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Acronym**

ENLIGHTEN-1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Short title**

A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Official title**

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

## Dates

**Completion date**

2030-07-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**First posted**

2026-01-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Registry last updated**

2026-08-21

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Primary completion date**

2028-03-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Start date**

2026-02-06

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

## Size and sites

**Participants**

1,980

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Planned participants**

1,980

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Protocol amendments**

0

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Number of sites**

162

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Lead sponsor**

Eli Lilly and Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

## Identifiers

**Registry ID**

NCT07321886

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**ClinicalTrials.gov ID**

NCT07321886

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Double masking

**Masked roles**

Participants, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

## Outcomes

### Primary outcomes

1. Percent Change from Baseline in Body Weight  
Timeframe: Baseline, Week 64

### Secondary outcomes

1. Percent Change from Baseline in Total Body Fat Mass  
Timeframe: Baseline, Week 64
2. Change from Baseline in Waist Circumference  
Timeframe: Baseline, Week 64
3. Percent Change from Baseline in Triglycerides  
Timeframe: Baseline, Week 64
4. Change from Baseline in Systolic Blood Pressure (SBP)  
Timeframe: Baseline, Week 64
5. Time to Onset of Type 2 Diabetes (T2D)  
Timeframe: Baseline to Week 168 and Week 191  
Time to Onset of Type 2 Diabetes (T2D) in Participants with Prediabetes at Randomization
6. Change from Baseline in Body Mass Index (BMI)  
Timeframe: Baseline, Week 64
7. Change from Baseline in Hemoglobin A1c (HbA1c)  
Timeframe: Baseline, Week 64
8. Percent Change from Baseline in Fasting Insulin  
Timeframe: Baseline, Week 64
9. Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)  
Timeframe: Baseline, Week 64
10. Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)  
Timeframe: Baseline, Week 64
11. Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Score  
Timeframe: Baseline, Week 64
12. Change from Baseline in EQ-5D-5L  
Timeframe: Baseline, Week 64
13. Change from Baseline in Control of Eating Questionnaire (CoEQ) Score  
Timeframe: Baseline, Week 64
14. Achievement of Improved Categorical Shift in Patient Global Improvement of Status (PGIS) Physical Function Weight  
Timeframe: Baseline, Week 64
15. Change in Medication Use  
Timeframe: Baseline through Week 64
16. Percent Change from Baseline in Body Weight in Participants with Prediabetes at Randomization  
Timeframe: Baseline, Week 168
17. Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss)  
Timeframe: Baseline through Week 64
18. PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)  
Timeframe: Baseline through Week 64

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

### Inclusion criteria

- Have Body Mass Index (BMI) at screening of the following:

  - 30 kilogram per square meter (kg/m2) OR
  - 27 kg/m2 with at least one of the following weight-related health conditions at screening:

    - high blood pressure
    - dyslipidemia
    - obstructive sleep apnea, or
    - heart disease
- Have a stable body weight (<5% body weight change) for 90 days prior to screening.
- Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight

### 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 or type 2 diabetes
- Have had within 90 days prior to screening:

  - heart attack
  - stroke
  - coronary artery revascularization
  - unstable angina, or
  - hospitalization due to congestive heart failure
- 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

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

## Sites

- MFA Clinical ResearchTuscaloosa, United StatesRecruiting
- Headlands Research - ScottsdaleScottsdale, United StatesRecruiting
- Neighborhood Healthcare Institute of HealthEscondido, United StatesRecruiting
- Ark Clinical Research - Fountain ValleyFountain Valley, United StatesRecruiting
- Desert Oasis Healthcare Medical GroupPalm Springs, United StatesRecruiting
- Peninsula Research AssociatesRolling Hills Estates, United StatesRecruiting
- Care Access - SacramentoSacramento, United StatesRecruiting
- Southern California Clinical ResearchSanta Ana, United StatesRecruiting
- University Clinical Investigators, Inc.Tustin, United StatesRecruiting
- Chase Medical Research, LLCWaterbury, United StatesRecruiting
- JEM Research InstituteAtlantis, United StatesRecruiting
- BioMed Research & Medical CenterMiami, United StatesRecruiting
- Adult Medicine of Lake County, Inc.Mt. Dora, United StatesRecruiting
- American Research Centers of FloridaPembroke Pines, United StatesRecruiting
- AHF PensacolaPensacola, United StatesRecruiting
- IMA Clinical Research St. PetersburgSt. Petersburg, United StatesRecruiting
- Teak Research Consults - DunwoodyDunwoody, United StatesRecruiting
- Teak Research ConsultsLawrenceville, United StatesRecruiting
- Clinical Research AtlantaStockbridge, United StatesRecruiting
- East-West Medical Research InstituteHonolulu, United StatesRecruiting
- Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United StatesRecruiting
- Cotton O'Neil Clinical Research CenterTopeka, United StatesRecruiting
- Care Access - Lake Charles (Bayou Pines)Lake Charles, United StatesRecruiting
- MedStar Good Samaritan HospitalBaltimore, United StatesRecruiting
- MedStar Health Research Institute (MedStar Physician Based Research Network)Hyattsville, United StatesRecruiting

And 137 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

## References

### Other registry identifiers (3)

- 2025
- 2025-523657-34-00
- J3R-MC-YDAG

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07321886)

## Related records

### Drugs (1)

- [Eloralintide](https://trialight.com/data/asset/eloralintide-ccf70d16-4bb8-42b3-b3e3-491d8fbd44a8.md)

### Lead sponsors (1)

- [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md)

### Conditions (1)

- [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition

---

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