Obesity, Overweight
Conditions
Brief summary
The purpose of this study is to learn how well orforglipron works and how safe it is in Chinese adults with obesity or overweight and related health problems. Participation in this study will last about 53 weeks (about 1 year).
Interventions
DRUGOrforglipron
Administered orally.
DRUGPlacebo
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have body mass index (BMI) ≥28.0 kilograms per square meter (kg/m2) and \<30 kg/m2 or ≥24.0 kg/m2 and \<28 kg/m2, and at least 1 of the following weight-related comorbidities at screening: * hypertension * dyslipidemia * obstructive sleep apnea * Fatty liver * cardiovascular disease * Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
Exclusion criteria
* Have type 1 diabetes (T1D), type 2 diabetes (T2D), or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma * Have a self-reported change in body weight \>5 kg within 90 days prior to screening * Had chronic or acute pancreatitis any time prior to screening * Have family (first-degree relative) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Percent Change From Baseline in Body Weight | Baseline, Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change from Baseline in Waist Circumference | Baseline, Week 48 |
| Mean Change from Baseline in Body Mass Index (BMI) | Baseline, Week 48 |
| Mean Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 48 |
| Mean Change from Baseline in Fasting Glucose | Baseline, Week 48 |
| Mean Percent Change from Baseline in Fasting Insulin | Baseline, Week 48 |
| Mean Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 48 |
| Mean Change from Baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 48 |
| Mean Percent Change from Baseline in Fasting non-HDL Cholesterol | Baseline, Week 48 |
| Mean Percent Change from Baseline in Fasting Triglycerides | Baseline, Week 48 |
| Mean Change from Baseline in Short Form Version 2 (SF-36v2) Acute Form Domain Scores | Baseline, Week 48 |
Countries
China
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed