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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Placebo; Drug: LY3502970

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital Sichuan University
  • Songjiang
    • Shanghai, Songjiang, China, 201620
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3502970 (Cohort 1); Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 milligram (mg), 3 mg, 6 mg and then 12 mg LY3502970 administered orally once daily (QD) from Day 1 for 16 weeks.	Drug: LY3502970; Administered orally.
Experimental: LY3502970 (Cohort 2); Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.	Drug: LY3502970; Administered orally.
Placebo Comparator: Placebo; Participants received placebo administered orally QD.	Drug: Placebo; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Week 18 (Cohort 1) & Week 26 (Cohort 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 1)	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.	Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 2)	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.	Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose)
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)	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.	Cohort 1: Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose)
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)	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.	Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose)
PD: Change From Baseline in Body Mass Index	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.	Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
Pharmacodynamics (PD): Change From Baseline in Body Weight	PD: Change from baseline in body weight calculated as post-baseline value minus baseline value. Negative values indicate a decrease in body weight.	Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
PD: Change From Baseline in Waist Circumference	PD: Change from baseline in Waist Circumference calculated as post-baseline value minus baseline value. Negative values indicate a decrease in Waist Circumference.	Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
PD: Change From Baseline in Fasting Plasma Glucose	PD: Change From Baseline in Fasting Plasma Glucose calculated as post-baseline value minus baseline value. Negative values indicate a decrease from baseline	Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Actual): July 29, 2024
• Study Completion (Actual): July 29, 2024

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Chinese; Safety and Tolerability; LY3502970
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; orforglipron
• Other Study ID Numbers: 18610; J2A-GH-GZGX (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes