Obesity, Overweight, Diabetes Mellitus, Type 2
Conditions
Keywords
GIP, Amylin
Brief summary
The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.
Interventions
DRUGMacupatide
Administered SC
DRUGEloralintide
Administered SC
DRUGMacupatide Placebo
Administered SC
DRUGEloralintide Placebo
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Have type 2 diabetes * Have an HbA1c ≥7.5% to ≤10.5% at screening * Have been treated with any of the following, alone or in combination, for at least 3 months prior to screening * Diet and exercise * Stable dose of metformin * Sodium-glucose cotransporter-2 (SGLT2) inhibitor * Have had a stable body weight (\<5% body weight gain and/or loss) for the 3 months prior to screening * Have a BMI of 27 or greater at screening
Exclusion criteria
* Have any form of diabetes other than type 2 diabetes * Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening * Have any of the following cardiovascular conditions within 3 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years, exceptions include * basal or squamous cell skin cancer * in situ carcinomas of the cervix, or * in situ prostate cancer * Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months: * amylin RA * dual amylin and calcitonin RA * glucagon-like peptide-1 receptor (GLP-1) RA * glucose-dependent insulinotropic peptide (GIP)/GLP-1 RA * GLP-1/glucagon (GCG) RAs, or * GIP/GLP-1/GCG RAs * Have used excluded antihyperglycemic medications within 3 months prior to screening (including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinides * Have used insulin for diabetic control within the prior year (short term use in certain situations allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 32 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 32 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 32 |
| Change from Baseline in Fasting Glucose | Baseline, Week 32 |
Countries
Argentina, Australia, Puerto Rico, 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