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Not yet recruitingPhase 1

A Study of LY4167586 in Participants With Obesity or Overweight With or Without Type 2 Diabetes

A Phase 1, Randomized, Participant- and Investigator-Blinded, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Dose Regimens of LY4167586 in Participants With Obesity or Overweight With or Without Type 2 Diabetes

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
Not 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

  • 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 check how much LY4167586 gets into the bloodstream and how long it takes the body to eliminate it following a single administration."
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 the safety of LY4167586 and how well people with obesity or overweight tolerate it, with or without type 2 diabetes. Blood tests will measure how much of the drug enters the blood and how long the body takes to clear it after one dose. The study lasts about 53 to 89 weeks; except in Part B, people will have 5 to 7 research center stays of about 8 to 10 nights each.

The main purpose of this study is to look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight with or without Type 2 Diabetes. Blood tests will be performed to check how much LY4167586 gets into the bloodstream and how long it takes the body to eliminate it following a single administration. Participation in the study will last between approximately 53 to 89 weeks. For each participant (excluding those in Part B), the study will include between 5 and 7 stays in the Clinical Research Unit (CRU), each stay lasting between approximately 8 and 10 nights.

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

Eligibility

Who can join

  • In Singapore, participants must be 21.
  • Your weight must have changed by less than about 5% in the 3 months before screening, based on your report.
  • Parts A, B, D, and E: Your BMI, a measure of weight compared with height, must be 30 or higher. A BMI of 27 to under 30 also qualifies if you have high blood pressure, unhealthy blood fat levels, sleep apnea (breathing that stops and starts during sleep), or prediabetes (blood sugar above normal).
  • Part C: Your BMI must be at least 25, and you must have had type 2 diabetes for at least 6 months.
  • Part C: Your diabetes must be controlled with diet and exercise alone, or you must have taken a steady dose of metformin alone or with an SGLT-2 inhibitor (a type of diabetes drug) for at least 3 months.
  • Part C: Your HbA1c, a blood test showing average blood sugar, must be 6.5% to 10.0%.
  • Part D: All 4 of your biological grandparents must be of only Chinese ancestry and born in China.
  • Part E: All 4 of your biological grandparents must be of only Japanese ancestry and born in Japan.

Who can't join

  • You cannot join if you have, or have had, a serious heart, lung, liver, kidney, digestive, hormone, blood, or nervous system disorder that could affect how your body handles drugs, make the study drug unsafe for you, or make study results hard to understand. Type 2 diabetes is allowed in Part C.

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

Official eligibility criteria

Inclusion Criteria: * Participants must be 21 in Singapore. * Have had a self-reported stable weight for 3 months prior to screening (less than approximately 5 percent (%) body weight change. Part A, B, D, and E * Have a body mass index (BMI) of greater than or equal to 30 kilograms per square meter (kg/m²) or 27 to less than 30 kg/m² and previously diagnosed with at least one of the following weight-related comorbidities: * hypertension * dyslipidemia * obstructive sleep apnea, or * prediabetes. Part C * Have a BMI ≥25.0 kg/m² * Have a diagnosis of Type 2 Diabetes (T2D) for at least 6 months. * T2D controlled with diet and exercise alone or are on a stable dose of metformin alone, or in combination with a sodium-glucose co-transporter-2 inhibitor (SGLT-2i), for at least 3 months. * Have a hemoglobin (HbA1c) value of ≥6.5 % and ≤10.0%. Part D * To qualify as Chinese for this study, the participant must be at a minimum third-generation Chinese, defined as having all 4 of the participants' biological grandparents being of exclusive Chinese descent and born in China. Part E * To qualify as Japanese for this study, the participant must be at a minimum third-generation Japanese, defined as having all 4 of the participants' biological grandparents being of exclusive Japanese descent and born in Japan. Exclusion Criteria: * Have a significant history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine (except for T2D in Part C), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study drug, or of interfering with the interpretation of data.

Study sites (11)

CA

FL

GA

NJ

OH

TX