Obesity, Overweight
Conditions
Brief summary
The purpose of this study is to investigate the efficacy and safety of different retatrutide dose escalation schemes in participants without type 2 diabetes who have obesity or overweight. Participation in the study will last about 113 weeks.
Interventions
DRUGRetatrutide
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Phase 3b
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a Body Mass Index (BMI) at screening * ≥ 30 kilogram per square meter (kg/m2) OR * ≥ 27 kg/m2 with presence of at least one of the following weight-related conditions at screening: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease * Have at least one unsuccessful attempt to lose weight by dieting
Exclusion criteria
* Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days before screening * Have a prior or planned surgical treatment for obesity * Have type 1 diabetes or type 2 diabetes * Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * Have had within the past 90 days before screening: * heart attack * stroke * hospitalization for unstable angina or heart failure * Have New York Heart Association Functional Classification Class IV congestive heart failure * Have a history of chronic or acute pancreatitis * Have taken weight loss drugs, including over-the counter medications within 90 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 104 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Waist Circumference | Baseline, Week 104 |
| Percent Change from Baseline in Triglycerides | Baseline, Week 104 |
| Change from Baseline in Systolic Blood Pressure | Baseline, Week 104 |
| Percent Change from Baseline in High Sensitivity C-Reactive Protein | Baseline, Week 104 |
| Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-Lite-CT) Total Score | Baseline, Week 104 |
| Overall Treatment Satisfaction with Medication for Obesity (TS-MO) Scores | Week 104 |
| Pharmacokinetics (PK): Steady state Average Trough PK Concentration | Baseline through Week 104 |
Countries
Argentina, Canada, United States
Contacts
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