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Completed

NCT Number: NCT06023095

A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities

The main purpose of this study is to learn about the safety and tolerability of LY3502970 when given to Chinese participants with obesity or overweight with weight-related comorbidities. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive LY3502970, or placebo given orally. For each participant, the study will last about approximately 22- and 30-weeks for both cohort 1 and 2, respectively including screening period.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Are native Chinese males or females
  • Have had a stable body weight for the 3 months prior to randomization (less than 5% body weight change) and body mass index of ≥ 30.0 kilograms per square meter (kg/m²) or between 27.0 up to 30.0 kg/m² with at least 1 of the following weight-related comorbidities including Hypertension, Dyslipidemia, Cardiovascular disease, Obstructive sleep apnea

Exclusion criteria

  • Have any prior diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), or rare forms of diabetes mellitus
  • Have used or intend to use any prescription or over-the-counter medications or traditional Chinese treatments within 3 months prior to screening, exception of medications for the treatment of concurrent medical conditions with a stable dose
  • Have known allergies to GLP-1RAs, LY3502970, related compounds, any components of the formulation, or have a history of significant atopy
  • Are overweight or have obesity induced by other endocrinological disorders, diagnosed monogenetic, or syndromic forms of obesity
  • Have or plan to have a surgical, endoscopic or device-based treatment for obesity
  • Have a history or presence of psychiatric disorder, a moderately severe or severe depression status, or a significantly risk for suicide
  • Have a history of acute or chronic pancreatitis
  • Have a known self or family history of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma
  • Have other acute, chronic, or uncontrolled medical conditions, vital organ failure or abnormal laboratory value in the judgment of the investigator would make the participant inappropriate for entry into this study

Treatment and study plan

LY3502970

Drug

Administered orally.

Placebo

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 through Week 18 (Cohort 1) & Week 26 (Cohort 2)

    A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 1)

    Time frame: Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose)

    Pharmacokinetic parameter Cmax (maximum observed plasma concentration) of LY3502970 following multiple oral doses at escalating dose levels. Cmax was assessed at steady state using plasma concentration-time data collected at specified timepoints per protocol.

  2. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 2)

    Time frame: Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose)

    Pharmacokinetic parameter Cmax (maximum observed plasma concentration) of LY3502970 following multiple oral doses at escalating dose levels. Cmax was assessed at steady state using plasma concentration-time data collected at specified timepoints per protocol.

  3. PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 1)

    Time frame: Cohort 1: Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose)

    Pharmacokinetic parameter AUC0-24 of LY3502970 following multiple oral doses at escalating dose levels. AUC0-24 was derived using plasma concentration-time data collected at predefined time points over a 24-hour dosing interval at steady state per protocol.

  4. PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 2)

    Time frame: Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose)

    Pharmacokinetic parameter AUC0-24 of LY3502970 following multiple oral doses at escalating dose levels. AUC0-24 was derived using plasma concentration-time data collected at predefined time points over a 24-hour dosing interval at steady state per protocol.

  5. PD: Change From Baseline in Body Mass Index

    Time frame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

    PD: Change from baseline in Body Mass Index calculated as post-baseline value minus baseline value. Negative values indicate a decrease in Body Mass Index.

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

    Time frame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

    PD: Change from baseline in body weight calculated as post-baseline value minus baseline value. Negative values indicate a decrease in body weight.

  7. PD: Change From Baseline in Waist Circumference

    Time frame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

    PD: Change from baseline in Waist Circumference calculated as post-baseline value minus baseline value. Negative values indicate a decrease in Waist Circumference.

  8. PD: Change From Baseline in Fasting Plasma Glucose

    Time frame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

    PD: Change From Baseline in Fasting Plasma Glucose calculated as post-baseline value minus baseline value. Negative values indicate a decrease from baseline

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Multiple Dose Titration Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Chinese Participants Who Have Obesity or Are Overweight With Weight-related Comorbidities

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2023
Registry last updated
Jul 17, 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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