Overweight, Obesity
Conditions
Keywords
Type 2 Diabetes
Brief summary
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 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
* Have type 2 diabetes * Are on stable treatment for type 2 diabetes for at least 90 days prior to screening * Have a BMI ≥ 27 kg/m2 * Have a stable body weight (\<5% body weight change) for 90 days prior to 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: * amylin analogs * glucagon-like peptide-1 (GLP-1) receptor agonists * glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 (GIP/GLP) receptor agonists, or * 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 * 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 |
|---|---|
| Percent Change from Baseline in Total Body Fat Mass | Baseline, Week 64 |
| Change from Baseline in Waist Circumference | Baseline, Week 64 |
| Change from Baseline in Hemoglobin A1c (HbA1c) | 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 |
| Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP) | Baseline, Week 64 |
| Percent Change from Baseline in Fasting Insulin | Baseline, Week 64 |
| Change in Medication Use | Baseline through Week 64 |
| Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) | 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 |
| 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, China, Czechia, Germany, India, Japan, Mexico, Poland, Puerto Rico, Slovakia, South Korea, 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