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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Phone Number: 1-317-615-4559
- Email: ClinicalTrials.gov@lilly.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Guangdong Provincial People's Hospital
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital Sichuan University
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Songjiang
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Shanghai, Songjiang, China, 201620
- Shanghai General Hospital
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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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.
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Administered orally.
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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.
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Administered orally.
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Placebo Comparator: Placebo
Participants received placebo administered orally QD.
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Administered orally.
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What is the study measuring?
Primary Outcome Measures
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
Time Frame: Baseline through Week 18 (Cohort 1) & Week 26 (Cohort 2)
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A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
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Baseline through Week 18 (Cohort 1) & Week 26 (Cohort 2)
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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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.
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Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose)
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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)
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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.
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Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose)
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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)
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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.
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Cohort 1: Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose)
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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)
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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.
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Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose)
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PD: Change From Baseline in Body Mass Index
Time Frame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
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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.
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Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
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Pharmacodynamics (PD): Change From Baseline in Body Weight
Time Frame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
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PD: Change from baseline in body weight calculated as post-baseline value minus baseline value.
Negative values indicate a decrease in body weight.
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Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
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PD: Change From Baseline in Waist Circumference
Time Frame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
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PD: Change from baseline in Waist Circumference calculated as post-baseline value minus baseline value.
Negative values indicate a decrease in Waist Circumference.
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Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
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PD: Change From Baseline in Fasting Plasma Glucose
Time Frame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
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PD: Change From Baseline in Fasting Plasma Glucose calculated as post-baseline value minus baseline value.
Negative values indicate a decrease from baseline
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Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
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)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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