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

NCT06023095 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18610J2A-GH-GZGX
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Overweight; Obesity

Keywords

Safety and Tolerability; Chinese; LY3502970

Outcome Measures

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

  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 Outcomes (6)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970

  Predose on Day 1 up to 116 (Cohort 1) & 172 (Cohort 2) Days postdose

• PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 hour Time Point (AUC0-24) of LY3502970

  Predose on Day 1 up to 116 (Cohort 1) & 172 (Cohort 2) Days postdose

• Pharmacodynamics (PD): Change From Baseline in Body Weight

  Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

• PD: Change From Baseline in Body Mass Index

  Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

• PD: Change From Baseline in Waist Circumference

  Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

Study Arms (2)

LY3502970

EXPERIMENTAL

LY3502970 administered orally

Drug: LY3502970

Placebo

PLACEBO COMPARATOR

Placebo administered orally

Drug: Placebo

Interventions

LY3502970 DRUG

Administered orally.

LY3502970

Placebo DRUG

Administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, 610041, China

Location

Shanghai General Hospital

Shanghai, Songjiang, 201620, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

orforglipron

Condition Hierarchy (Ancestors)

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

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: September 21, 2023
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)