Obesity, Overweight
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.
Interventions
DRUGEloralintide
Administered SC
DRUGPlacebo
Administered SC
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) at screening of the following: * 30 kilogram per square meter (kg/m2) OR * 27 kg/m2 with at least one of the following weight-related health conditions at screening: * high blood pressure * dyslipidemia * obstructive sleep apnea, or * heart disease * Have a stable body weight (\<5% body weight change) for 90 days prior to screening. * Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight
Exclusion criteria
* Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \>1 year before screening) * Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening) * Have type 1 diabetes or type 2 diabetes * Have had within 90 days prior to screening: * heart attack * stroke * coronary artery revascularization * unstable angina, or * hospitalization due to congestive heart failure * Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure * Have taken medications or alternative remedies intended for weight loss within 90 days of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 64 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change from Baseline in Total Body Fat Mass | Baseline, Week 64 | — |
| Change from Baseline in Waist Circumference | Baseline, Week 64 | — |
| Percent Change from Baseline in Triglycerides | Baseline, Week 64 | — |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 64 | — |
| Time to Onset of Type 2 Diabetes (T2D) | Baseline to Week 168 and Week 191 | Time to Onset of Type 2 Diabetes (T2D) in Participants with Prediabetes at Randomization |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 64 | — |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 64 | — |
| Percent Change from Baseline in Fasting Insulin | Baseline, Week 64 | — |
| Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | Baseline, Week 64 | — |
| Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) | Baseline, Week 64 | — |
| Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Score | Baseline, Week 64 | — |
| Change from Baseline in EQ-5D-5L | Baseline, Week 64 | — |
| Change from Baseline in Control of Eating Questionnaire (CoEQ) Score | Baseline, Week 64 | — |
| Achievement of Improved Categorical Shift in Patient Global Improvement of Status (PGIS) Physical Function Weight | Baseline, Week 64 | — |
| Change in Medication Use | Baseline through Week 64 | — |
| Percent Change from Baseline in Body Weight in Participants with Prediabetes at Randomization | Baseline, Week 168 | — |
| Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss) | Baseline through Week 64 | — |
| PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss) | Baseline through Week 64 | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Germany, India, Japan, Poland, Puerto Rico, South Korea, Taiwan, United Kingdom, United States
Contacts
CONTACTTrial question 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