Recruiting NCT07282600

A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes

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, Argentina, China, Czechia, Germany +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 Obesity or Overweight, and Type 2 Diabetes

Overview

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.

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)

Percent Change from Baseline in Total Body Fat Mass [Time frame: Baseline, Week 64]
Change from Baseline in Waist Circumference [Time frame: Baseline, Week 64]
Change from Baseline in Hemoglobin A1c (HbA1c) [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]
Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP) [Time frame: Baseline, Week 64]
Percent Change from Baseline in Fasting Insulin [Time frame: Baseline, Week 64]
Change in Medication Use [Time frame: Baseline through Week 64]
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) [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]

Eligibility criteria

Inclusion criteria

Have type 2 diabetes
Are on stable treatment for type 2 diabetes for at least 90 days prior to screening
Have a BMI ≥ 27 kg/m2
Have a stable body weight (<5% body weight change) for 90 days prior to 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:

amylin analogs
glucagon-like peptide-1 (GLP-1) receptor agonists
glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 (GIP/GLP) receptor agonists, or
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
Have taken medications or alternative remedies intended for weight loss within 90 days of screening

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

Study locations

United States · 60 centers

Birmingham Clinical Research — Birmingham
Cullman Clinical Trials — Cullman
Tucson Clinical Research Institute — Tucson
San Fernando Valley Health Institute — Canoga Park
AMCR Institute — Escondido
NorCal Medical Research, Inc — Greenbrae
Ark Clinical Research — Long Beach
Pacific Clinical Studies — Los Alamitos
… and 52 more centers

China · 16 centers

Luhe Hospital — Beijing
Peking University People's Hospital — Beijing
Beijing Pinggu District Hospital — Beijing
Sichuan Provincial People's Hospital — Chengdu
The Second Affiliated Hospital Chongqing Medical University — Chongqing
Zhujiang Hospital — Guangzhou
The Second People's Hospital of Hefei — Hefei
Jinan Central Hospital — Jinan
… and 8 more centers

Japan · 15 centers