Overweight, Obesity
Conditions
Keywords
Amylin receptor agonist
Brief summary
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy. Participation in the study will last about 80 weeks.
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
* Are on stable incretin therapy at screening * With persistent obesity or overweight defined as: * ≥30 kg/m2 OR * ≥27 kg/m2 with at least one existing obesity related complication at screening: * hypertension * dyslipidemia * obstructive sleep apnea * cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or * type 2 diabetes * Have a stable body weight (\<5% body weight change) at screening
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 * Have taken any of the following antihyperglycemic medications within 90 days before screening: * dipeptidyl peptidase-4 (DPP-4) inhibitors * amylin analogs * insulin * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 64 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Waist Circumference | Baseline, Week 64 |
| Percent Change in Baseline in Triglycerides | Baseline, Week 64 |
| Change from Baseline in Systolic Blood Pressure | Baseline, Week 64 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 64 |
| Change from Baseline in Fasting Glucose in Participants with Type 2 Diabetes at Baseline | Baseline, Week 64 |
| Change from Baseline in Short Form-36 (SF-36 v2) Score | Baseline, Week 64 |
| Change from Baseline in EQ-5D-5L Score | Baseline, Week 64 |
| Change from Baseline in Control of Eating Questionnaire (CoEQ) Score | Baseline, Week 64 |
| Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight | 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 in Medication Use | Baseline through Week 64 |
| 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
Australia, Belgium, Brazil, China, Czechia, India, Israel, Japan, Mexico, Puerto Rico, Romania, Spain, Taiwan, United States
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