Testing LY4329090 in adults with overweight or obesity who are otherwise healthy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study assesses tolerability, safety, and pharmacokinetics of LY4329090 versus placebo in adults with BMI 27.0–40.0 kg/m² who are otherwise healthy. The trial has two parts: Part A involves a ~10-week stay with 5 nights in a Clinical Research Unit and 5 outpatient visits; Part B lasts ~21 weeks with four CRU stays totaling 11 nights and 14 outpatient visits. Participants are randomized to receive LY4329090 or placebo to understand how the drug is processed in the body and its effects, with extensive monitoring and blood tests. The study excludes individuals with major cardiovascular, hepatic, renal, or other chronic conditions and certain ECG abnormalities to focus on safety and basic pharmacology in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Have received any drugs from the incretins class within 90 days prior to screening.
* Have been treated within 3 months prior to screening or plan to be treated with prescription medications that promote weight loss.
* Intend to use any weight loss medications during study participation.
* Prior (within 6 months) or planned (during the study) device-based treatment use for obesity.

Where it's running

• Fortrea Clinical Research Unit
  Daytona Beach, Florida, United States Recruiting
• Fortrea Clinical Research Unit
  Dallas, Texas, United States Recruiting
• Lilly Centre for Clinical Pharmacology
  Singapore, Singapore Not yet recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.