A Study of Eloralintide (LY3841136) in Participants With Obesity or 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, Acetaminophen.
- Who it may be relevant to
- Registry conditions: Obesity, Overweight. Basic parameters: 18 years — 65 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, Singapore
- 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 1, Investigator- and Participant-Blinded, Placebo-Controlled, Randomized, Multiple-Dose Study to Evaluate the Gastric Emptying Delay, Pharmacokinetics, Safety, and Tolerability of Eloralintide in Participants With Obesity or Overweight
Overview
The main purpose of this study is to find out how significantly Eloralintide slows stomach emptying in participants who are overweight or obese. For each participant, the study will last approximately 21 weeks and will include 2 overnight stays in the clinical research unit (CRU) lasting between 4 and 8 days. There will be 13 other visits.
Interventions
- Drug Eloralintide
Administered SC - Drug Placebo
Administered SC - Drug Acetaminophen
Administered Oral Solution
Primary outcome measures
- Acetaminophen Area Under the Concentration Versus Time Curve (AUC) [Time frame: Baseline to Day 65]
- Acetaminophen Maximum Observed Concentration (Cₘₐₓ) [Time frame: Baseline to Day 65]
- Acetaminophen Time to Maximum Observed Drug Concentration (tₘₐₓ) [Time frame: Baseline to Day 65]
Secondary outcome measures (2)
- Eloralintide AUC [Time frame: Baseline to Day 106]
- Eloralintide Cₘₐₓ [Time frame: Baseline to Day 106]
Eligibility criteria
Inclusion criteria
- Have overweight or obesity, but are otherwise overtly healthy.
- Have a body mass index (BMI) within the range of 27.0 to 45.0 kilograms (kg)/square meter (m²), inclusive.
- Have had a stable body weight, with less than 5 percent (%) change during the 3-month period prior to screening.
Exclusion criteria
- Have been diagnosed with Type 1 or Type 2 diabetes mellitus, or have either of the following at screening
- A fasting plasma glucose concentration greater than or equal to 126 milligrams (mg)/deciliter (dL) or 7.0 millimoles (mmol)/liter (L), or
- Hemoglobin A1C (HbA1c) greater than or equal to 6.5% or 48 mmol/mole (mol).
- Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, and bipolar disorder, within the last 2 years.
- Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, or GIP/GLP-1/glucagon receptor agonist within 60 days or 5 half-lives, whichever is longer, prior to screening.
- Are in the judgment of the investigator, actively suicidal or deemed to be at significant risk for suicide.
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
United States · 1 center
- ICON Early Phase Services — San Antonio
Singapore · 1 center
- Lilly Centre for Clinical Pharmacology — Singapore
Identifiers
NCT: NCT07738614 · 27759 · J3R-MC-YDAP