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Completed

NCT Number: NCT05313802

A Study of LY3502970 in Healthy Overweight and Obese Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3502970 in healthy overweight and obese participants. The blood tests will be conducted to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in these participants. The study will last up to 42 days excluding the screening period.

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Key information

Conditions

Healthy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Qps-Mra, Llc, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with stable body weight for at least one month prior to randomization.
  • Participants with body mass index (BMI) of greater than or equal to (≥) 27.0 kilograms per meter squared (kg/m²)
  • Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion criteria

  • Have known allergies to LY3502970 or other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs
  • Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders
  • Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %

Treatment and study plan

LY3502970

Drug

Administered orally.

Primary outcomes

  1. Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline up to Day 42

    A TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is any adverse event from this study that results in one of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. An overall summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1

    Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

    PK: AUC[0-tlast] of LY3502970

  2. PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1

    Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

    PK: Cmax of LY3502970

  3. PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 on Day 1

    Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

    PK: Tmax of LY3502970

  4. PK: AUC[0-tlast] of LY3502970 on Day 28

    Time frame: Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

    PK: AUC[0-tlast] of LY3502970

  5. PK: Cmax of LY3502970 on Day 28

    Time frame: Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

    PK: Cmax of LY3502970

  6. PK: Tmax of LY3502970 on Day 28

    Time frame: Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

    PK: Tmax of LY3502970

  7. Pharmacodynamics (PD): Change From Baseline in Body Weight

    Time frame: Baseline through Day 29

    PD: Change From Baseline in Body Weight

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Multiple Dose Study in Healthy Overweight and Obese Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2022
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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