RightFit
RecruitingPhase 1

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

A Phase 1, Participant- and Investigator-Blind, Single-Ascending and Multiple- Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4329090 in Participants With Obesity or Overweight

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits, 14 visits
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well people tolerate LY4329090 and what side effects it may cause. It is for adults with obesity or overweight who are otherwise healthy. Blood tests will check how the body processes the drug and how the drug affects the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 65 years old, or 21 to 65 at the Singapore site.
  • Are otherwise healthy, with no health problems linked to body weight.
  • Have a body mass index (BMI), a measure of weight compared with height, from 27 to 40.
  • Report that your weight has been stable for the past 3 months.

Who can't join

  • Have current or past disorders of the heart, lungs, liver, kidneys, digestive system, hormones, blood, or nerves.
  • Have an abnormal blood pressure or pulse at screening; a resting pulse below 50 beats per minute; certain blocked heart signals on a heart tracing (ECG); or past symptoms from a slow heartbeat whose cause has not been fixed.
  • Have obesity caused by another hormone disorder, a single gene change, or a diagnosed genetic syndrome.
  • Have diagnosed low or high calcium, or confirmed abnormal blood levels of calcium or phosphorus.
  • Have a serious problem with how your stomach empties; have had weight loss surgery or treatment using a scope or device; had an obesity device used or removed in the past 6 months; or plan device treatment during the study.
  • Have type 1 or type 2 diabetes, or an A1c blood sugar test result of 6.5% or higher at screening.
  • Have had a mental health disorder in the past 2 years that could make the study unsafe or make it hard to follow study steps.
  • Used blood sugar-lowering drugs in the past 3 months, incretin drugs (a class of medicines) in the past 90 days, or prescription weight loss drugs in the past 3 months; or plan to use weight loss medicines during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

FL

TX