A Study of LY4329090 in Participants With Obesity or Overweight Who Are Otherwise Healthy

NCT07808073 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27900J7O-MC-YVAA
• Study Type: interventional
• Target: 184
• Locations: 2 countries
• Sites: 3

Brief Summary

The main purpose of this study is to assess how well LY4329090 is tolerated and what side effects may occur in healthy participants with obesity or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Study participants will be in one of 2 parts. For each participant in Part A, the study will last about 10 weeks and will include a stay in the Clinical Research Unit (CRU) lasting 5 nights along with 5 outpatient visits to the CRU. For each participant in Part B, the study will last about 21 weeks and will include 4 stays totaling 11 nights along with 14 outpatient visits to the CRU.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  End of Study (Week 28)

Secondary Outcomes (4)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4329090

  Baseline through Week 28

• PK: Time of Maximum Observed Drug Concentration (Tmax) of LY4329090

  Baseline through Week 28

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY4329090

  Baseline through Week 28

• Pharmacodynamics (PD): Body Weight Change from Baseline

  Baseline through Week 28

Study Arms (4)

LY4329090 Part A

EXPERIMENTAL

Participants will receive LY4329090 administered subcutaneously (SC)

Drug: LY4329090

Placebo Part A

EXPERIMENTAL

Participants will receive placebo administered SC

Drug: Placebo

LY4329090 Part B

EXPERIMENTAL

Participants will receive LY4329090 administered SC

Drug: LY4329090

Placebo Part B

PLACEBO COMPARATOR

Participants will receive placebo administered SC

Drug: Placebo

Interventions

LY4329090 DRUG

Administered SC

LY4329090 Part A; LY4329090 Part B

Placebo DRUG

Administered SC

Placebo Part A; Placebo Part B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18 (21 for Singapore site) to 65 years of age, inclusive, at the time of signing the informed consent.
• Are overtly healthy with no comorbidities related to body mass index (BMI).
• Have a BMI between 27.0 kilograms per square meter (kg/m²) and 40.0 kg/m², inclusive.
• Have had a self-reported stable weight for 3 months prior to screening.

You may not qualify if:

• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders.
• Have a history of chronic medical conditions involving the heart, liver, or kidneys.
• Have either
• ongoing asymptomatic bradycardia defined as less than 50 beats per minute at screening visit
• electrocardiogram (ECG) findings at screening visit of second-degree atrioventricular block or higher, or
• history of symptomatic bradycardia with uncorrected etiology, including diagnosis of sick sinus syndrome.
• Have an abnormal blood pressure and/or pulse rate at screening.
• Have an obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
• Have any of the following:
• a diagnosis of hypocalcemia or hypercalcemia, or
• confirmed abnormal laboratory values for calcium and serum phosphorus.
• Have a known, clinically significant gastric emptying abnormality, have undergone weight loss surgery, or have had endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months.
• Have been diagnosed with type 1 or type 2 diabetes mellitus or have glycated hemoglobin A1c (HbA1c) greater than or equal to (≥) 6.5 percent (%) or 48 millimoles per mole (mmol/mol) at screening.
• Have a history or presence of psychiatric disorders, within the last 2 years, that would present a safety risk or may significantly impair the participant's ability to comply with study procedures.
• Have taken any glucose-lowering medications, including insulin, in the past 3 months before screening.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 8, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); US (2)