A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight | NCT07738614

NCT07738614

Overview

NCT ID: NCT07738614
Lead Sponsor: Eli Lilly and CompanyINDUSTRY
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
Brief Summary: 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.
Conditions: Obesity
Overweight
Interventions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
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.

Central Contacts: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orContact
LillyTrials@Lilly.com

Participant Group/Arms

Eloralintide Cohort 1Experimental

Eloralintide administered subcutaneously (SC)

Drug: Eloralintide

Drug: Acetaminophen

Eloralintide Cohort 2Experimental

Eloralintide administered SC

Drug: Eloralintide

Eloralintide Cohort 3Experimental

Eloralintide administered SC

Drug: Eloralintide

Eloralintide Cohort 4Experimental

Eloralintide administered SC

Drug: Eloralintide

PlaceboPlacebo Comparator

Placebo administered SC

Drug: Placebo