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

Lilly

Status and phase: Not yet enrolling; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: Eloralintide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06916091

27320

J3R-MC-YDAD (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate how well Eloralintide (LY3841136) is tolerated and what side effects may occur in overweight and obese Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much Eloralintide gets into the bloodstream and how long it takes the body to eliminate it.

The study will last approximately 10 weeks excluding a screening period.

Enrollment: 36 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chinese participants. To qualify as Chinese, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
• Have had a stable body weight for 3 months prior to screening. Participants with body weight change of less than 5% will be allowed
• Have not modified diet or adopted any nutritional lifestyle modification for 3 months before randomization
• Have clinical laboratory test results within a normal range for the population or investigative site at screening and lead-in, or results with acceptable deviations that are judged to be not clinically significant by the investigator
• Have a body mass index (BMI) within the range 27 to 40 kilogram per square meter (kg/m²)

Exclusion criteria

• Are pregnant, or intend to become pregnant or to breastfeed during the study

• Have known allergies to related compounds of eloralintide

• Have any of the following abnormal blood pressure (BP) and/or pulse rate at screening, constituting a risk when taking the investigational product with minor deviations judged to be acceptable by the investigator:

  • Supine BP > 160/90 millimeter mercury (mmHg)
  • Supine pulse rate < 50 or > 100 beats per minute (bpm)
  • Orthostatic hypotension

• Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs

• Regularly use known drugs of abuse and/or show positive findings on drug screening that are not consistent with the medical history or concomitant medication history

• Have donated blood of more than 450 mL within the previous 3 months of study screening, or intend to donate blood during the course of the study

• Have a history of chronic medical conditions involving the heart, liver, or kidneys

• Have a medical history or current evidence of clinically significant cardiac condition

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

Eloralintide

Experimental group

Description:

Eloralintide administered subcutaneously (SC)

Treatment:

Drug: Eloralintide

Placebo

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo