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Recruiting NCT07321886

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

Phase III Interventional Obesity Overweight

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: Obesity, Overweight. 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, Australia, Belgium, Brazil +10
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, Without Type 2 Diabetes

Overview

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.

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]
  • Percent Change from Baseline in Triglycerides [Time frame: Baseline, Week 64]
  • Change from Baseline in Systolic Blood Pressure (SBP) [Time frame: Baseline, Week 64]
  • Time to Onset of Type 2 Diabetes (T2D) [Time frame: Baseline to Week 168 and Week 191]
  • Change from Baseline in Body Mass Index (BMI) [Time frame: Baseline, Week 64]
  • Change from Baseline in Hemoglobin A1c (HbA1c) [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]
  • Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Score [Time frame: Baseline, Week 64]
  • Change from Baseline in EQ-5D-5L [Time frame: Baseline, Week 64]

Eligibility criteria

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

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 · 41 centers
  • MFA Clinical Research — Tuscaloosa
  • Headlands Research - Scottsdale — Scottsdale
  • Neighborhood Healthcare Institute of Health — Escondido
  • Ark Clinical Research - Fountain Valley — Fountain Valley
  • Desert Oasis Healthcare Medical Group — Palm Springs
  • Peninsula Research Associates — Rolling Hills Estates
  • Care Access - Sacramento — Sacramento
  • Southern California Clinical Research — Santa Ana
  • … and 33 more centers
China · 14 centers

Center list to be confirmed — check the primary protocol.

Germany · 13 centers

Center list to be confirmed — check the primary protocol.

Australia · 11 centers
  • Emeritus Research — Botany
  • Core Research Group — Brisbane
  • Emeritus Research — Camberwell
  • Life Clinical Research — Ipswich
  • Paratus Clinical Research Central Coast — Kanwal
  • University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook — Meadowbrook
  • Momentum Sunshine — Melbourne
  • Paratus Clinical Research - Melbourne — Melbourne
  • … and 3 more centers
Brazil · 11 centers
  • Chronos Pesquisa Clínica — Brasília
  • Instituto de Pesquisa clinica de Campinas — Campinas
  • Private Practice - Dr.Miguel N. Hissa — Fortaleza
  • Centro de Pesquisa Clínica de Marília - CPCLIM — Marília
  • Núcleo de Pesquisa Clínica do Rio Grande do Sul — Porto Alegre
  • IBPClin - Instituto Brasil de Pesquisa Clínica — Rio de Janeiro
  • Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro
  • CPCLIN — São Paulo
  • … and 3 more centers
Argentina · 10 centers
  • CONEXA Investigacion Clinica S.A. — Buenos Aires
  • Cicemo Srl — Buenos Aires
  • Cardiología Palermo — Buenos Aires
  • Glenny Corp. S.A. — Buenos Aires
  • CARDIAMET Investigaciones Médicas — Buenos Aires
  • Centro Médico Viamonte — Buenos Aires
  • Fundación Respirar — Buenos Aires
  • Instituto de Investigaciones Clínicas Córdoba — Córdoba
  • … and 2 more centers
India · 10 centers

Center list to be confirmed — check the primary protocol.

Canada · 9 centers
  • Aggarwal and Associates Limited — Brampton
  • Med Trust Research — Courtice
  • Dawson Clinical Research Inc. — Guelph
  • … and 6 more centers
Japan · 9 centers

Center list to be confirmed — check the primary protocol.

Poland · 9 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 9 centers

Center list to be confirmed — check the primary protocol.

South Korea · 5 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 5 centers

Center list to be confirmed — check the primary protocol.

Belgium · 4 centers
  • ANIMA Research — Diepenbeek
  • Jessa Ziekenhuis — Hasselt
  • Kormont — Kluisbergen
  • Gezondheidshuis De Gloed — Machelen
Puerto Rico · 2 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07321886 · 27742 · J3R-MC-YDAG · 2025-523657-34-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗