Recruiting NCT07392190

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

Phase III Interventional Overweight Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Eloralintide, Placebo.
Who it may be relevant to: Registry conditions: Overweight, Obesity. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, Brazil, China +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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 Persistent Obesity or Overweight Treated With a Weekly Incretin, With and Without Type 2 Diabetes

Overview

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy. Participation in the study will last about 80 weeks.

Interventions

Drug Eloralintide
Administered SC
Drug Placebo
Administered SC

Primary outcome measures

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

Secondary outcome measures (12)

Change from Baseline in Waist Circumference [Time frame: Baseline, Week 64]
Percent Change in Baseline in Triglycerides [Time frame: Baseline, Week 64]
Change from Baseline in Systolic Blood Pressure [Time frame: Baseline, Week 64]
Change from Baseline in Body Mass Index (BMI) [Time frame: Baseline, Week 64]
Change from Baseline in Fasting Glucose in Participants with Type 2 Diabetes at Baseline [Time frame: Baseline, Week 64]
Change from Baseline in Short Form-36 (SF-36 v2) Score [Time frame: Baseline, Week 64]
Change from Baseline in EQ-5D-5L Score [Time frame: Baseline, Week 64]
Change from Baseline in Control of Eating Questionnaire (CoEQ) Score [Time frame: Baseline, Week 64]
Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight [Time frame: Baseline, Week 64]
Percent Change from Baseline in Fasting Insulin [Time frame: Baseline, Week 64]
Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP) [Time frame: Baseline, Week 64]
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) [Time frame: Baseline, Week 64]

Eligibility criteria

Inclusion criteria

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

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:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment