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Recruiting NCT07215559

A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes

Phase II Interventional Obesity Overweight Diabetes Mellitus, Type 2

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: Macupatide, Eloralintide, Macupatide Placebo, Eloralintide Placebo.
Who it may be relevant to
Registry conditions: Obesity, Overweight, Diabetes Mellitus, Type 2. Basic parameters: 18 years — 75 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, Puerto Rico
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 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Reduction With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and With Type 2 Diabetes

Overview

The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.

Interventions

  • Drug Macupatide
    Administered SC
  • Drug Eloralintide
    Administered SC
  • Drug Macupatide Placebo
    Administered SC
  • Drug Eloralintide Placebo
    Administered SC

Primary outcome measures

  • Percent Change from Baseline in Body Weight [Time frame: Baseline, Week 32]
Secondary outcome measures (3)
  • Change from Baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline, Week 32]
  • Change from Baseline in Body Mass Index (BMI) [Time frame: Baseline, Week 32]
  • Change from Baseline in Fasting Glucose [Time frame: Baseline, Week 32]

Eligibility criteria

Inclusion criteria

  • Have type 2 diabetes
  • Have an HbA1c ≥7.5% to ≤10.5% at screening
  • Have been treated with any of the following, alone or in combination, for at least 3 months prior to screening
  • Diet and exercise
  • Stable dose of metformin
  • Sodium-glucose cotransporter-2 (SGLT2) inhibitor
  • Have had a stable body weight (<5% body weight gain and/or loss) for the 3 months prior to screening
  • Have a BMI of 27 or greater at screening

Exclusion criteria

  • Have any form of diabetes other than type 2 diabetes
  • Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening
  • Have any of the following cardiovascular conditions within 3 months prior to screening:
  • acute myocardial infarction
  • cerebrovascular accident (stroke)
  • unstable angina, or
  • hospitalization due to congestive heart failure
  • Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years, exceptions include
  • basal or squamous cell skin cancer
  • in situ carcinomas of the cervix, or
  • in situ prostate cancer
  • Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months:
  • amylin RA
  • dual amylin and calcitonin RA
  • glucagon-like peptide-1 receptor (GLP-1) RA
  • glucose-dependent insulinotropic peptide (GIP)/GLP-1 RA
  • GLP-1/glucagon (GCG) RAs, or
  • GIP/GLP-1/GCG RAs
  • Have used excluded antihyperglycemic medications within 3 months prior to screening (including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinides
  • Have used insulin for diabetic control within the prior year (short term use in certain situations allowed

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 · 26 centers
  • Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC — Gilbert
  • Synexus Clinical Research US, Inc. — Phoenix
  • Pima Heart — Tucson
  • Precision Clinical Research — Sunrise
  • SKY Clinical Research Network Group-Brown — Atlanta
  • Teak Research Consults — Lawrenceville
  • AGILE Clinical Research Trials, LLC — Sandy Springs
  • Pivotal Research Solutions — Stonecrest
  • … and 18 more centers
Australia · 8 centers
  • Emeritus Research — Botany
  • Core Research Group — Brisbane
  • Emeritus Research — Camberwell
  • Cornerstone Dermatology — Coorparoo
  • Momentum Darlinghurst — Darlinghurst, Sydney
  • CDH Research Institute Pty Ltd — Maroochydore
  • Momentum Sunshine — Melbourne
  • AIM Research — Merewether
Argentina · 6 centers
  • Centro de Investigaciones Metabólicas (CINME) — Buenos Aires
  • CENUDIAB — Buenos Aires
  • CEDIC — CABA
  • Instituto de Investigaciones Clínicas Córdoba — Córdoba
  • Clínica Universitaria Reina Fabiola — Córdoba
  • Go Centro Medico San Nicolás — San Nicolás
Puerto Rico · 2 centers
  • San Juan Bautista School of Medicine - Clinical Research Unit — Caguas
  • Mgcendo Llc — San Juan

Identifiers

NCT: NCT07215559 · 27721 · J2V-MC-GZLF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗