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A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Persistent Obesity or Overweight Treated With a Weekly Incretin, With and Without Type 2 Diabetes (J3R-MC-YDAL)

A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin (J3R-MC-YDAL)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Recruiting

Mar. 16, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Are on stable incretin therapy at screening
- With persistent obesity or overweight defined as:
* >=30 kg/m2 OR
* >=27 kg/m2 with at least one existing obesity related complication at screening:
* hypertension
* dyslipidemia
* obstructive sleep apnea
* cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or
* type 2 diabetes
- Have a stable body weight (<5% body weight change) at screening

- 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:
* dipeptidyl peptidase-4 (DPP-4) inhibitors
* amylin analogs
* insulin
- 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

Both

Overweight
Obesity

DRUG: Eloralintide(Other Name: LY3841136)
Administered SC
DRUG: Placebo
Administered SC

(Study Arms)
Experimental: Eloralintide Dose 1
Participants will receive eloralintide subcutaneously (SC)
Interventions:
Drug: Eloralintide
Experimental: Eloralintide Dose 2
Participants will receive eloralintide SC
Interventions:
Drug: Eloralintide
Experimental: Eloralintide Dose 3
Participants will receive eloralintide SC
Interventions:
Drug: Eloralintide
Experimental: Eloralintide Dose 4
Participants will receive eloralintide SC
Interventions:
Drug: Eloralintide
Placebo Comparator: Placebo
Participants will receive placebo SC
Interventions:
Drug: Placebo

Percent Change from Baseline in Body Weight [Time Frame: Baseline, Week 64]

+81-422-22-8151

Jan. 22, 2026

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.

United States/Australia/Belgium/Brazil/China/Czechia/India/Israel/Mexico/Puerto Rico/Romania/Spain/Taiwan