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Recruiting NCT07665879

A Study of Eloralintide (LY3841136) in Participants With Overweight or Obesity

Phase I 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: 18 years — 70 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
Germany, Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Phase 1, Investigator- and Participant-Blinded Study to Evaluate the Effect of Eloralintide on Insulin Sensitivity and Metabolism in Adult Participants With Overweight or Obesity

Overview

The main purpose of the study is to measure and compare the effects of eloralintide and placebo on insulin sensitivity (how your body responds to insulin), metabolic health (things like sugar and cholesterol), and body weight in participants with obesity or overweight. For each participant, the study will last about 35 weeks and include 3 in patient visits totaling 7 days.

Interventions

  • Drug Eloralintide
    Eloralintide administered SC
  • Other Placebo
    Placebo administered SC

Primary outcome measures

  • Change From Baseline In Hyperinsulinemic Euglycemic Clamp (HEC) Predicted Clamp-Derived Insulin Sensitivity (M-value) [Time frame: Baseline, Week 24]
Secondary outcome measures (1)
  • Change From Baseline In Body Weight [Time frame: Baseline, Week 24]

Eligibility criteria

Inclusion criteria

  • Have an hemoglobin A1c (HbA1c) value at screening of less than 6.5 percent (%).
  • Have a body mass index between 25 and 45 Kilogram per Square Meter (kg/m²).
  • Have had a stable body weight that has changed by less than 5% during the 3 months prior to screening.
  • Are individuals assigned male at birth (AMAB) or assigned female at birth (AFAB). Individuals of childbearing potential (IOCBP) and individuals not of childbearing potential (INOCBP) may participate in this study.

Exclusion criteria

  • Have type 1 or type 2 diabetes mellitus, a history of ketoacidosis, or of hyperosmolar state or coma. Note: Participants with a history of gestational diabetes are eligible to participate in this study.
  • Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis.
  • Have a known clinically significant gastric emptying abnormality or chronically take drugs that directly affect gastrointestinal (GI) motility to a significant extent.
  • Have a prior or planned surgical treatment for obesity. Exceptions: The following are allowed if they occurred more than 1 year before screening:
  • liposuction
  • cryolipolysis, or
  • abdominoplasty.
  • Are unwilling to comply with the lifestyle and dietary restrictions required for this study.
  • Are individuals AFAB who are lactating.
  • Are individuals AFAB who are pregnant or intend to become pregnant or to breastfeed during the study, or individuals AMAB who intend to conceive a pregnancy during the study.

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

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Profil Institut für Stoffwechselforschung — Neuss
Sweden · 1 center
  • CTC GoCo — Mölndal

Identifiers

NCT: NCT07665879 · 27756 · J3R-MC-YDAK · 2025-523873-41-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗