Clinical trial NCT06023095: A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obesity
Keywords: Safety and Tolerability
Chinese
LY3502970
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-09-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline through Week 18 (Cohort 1) & Week 26 (Cohort 2)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
timeFrame: Predose on Day 1 up to 116 (Cohort 1) & 172 (Cohort 2) Days postdose
measure: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 hour Time Point (AUC0-24) of LY3502970
timeFrame: Predose on Day 1 up to 116 (Cohort 1) & 172 (Cohort 2) Days postdose
measure: Pharmacodynamics (PD): Change From Baseline in Body Weight
timeFrame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
measure: PD: Change From Baseline in Body Mass Index
timeFrame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
measure: PD: Change From Baseline in Waist Circumference
timeFrame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
measure: PD: Change From Baseline in Fasting Plasma Glucose
timeFrame: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Songjiang
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: