Obesity, Overweight
Conditions
Brief summary
The main purpose of this study is to assess how well macupatide, when dosed alone and in combination with eloralintide, is tolerated and what side effects may occur in participants with obesity or overweight without Type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 4 months and will include 2 stays in the Clinical Research Unit (CRU), each lasting 3-5 nights.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are Japanese participants assigned male at birth (AMAB) or assigned female at birth (AFAB) who agree to contraception requirements or participants who are individuals not of childbearing potential (INOCBP). * Have a body mass index greater than or equal to (≥)25 kilograms per square meter (kg/m²) * Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5 percent (%) body weight change.
Exclusion criteria
* Have known allergies to related compounds of macupatide or eloralintide, or any components of the formulations. * Have a history of significant atopy, including severe allergic manifestations, or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions. * Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders, within the last 3 years, that would present a safety risk or may significantly impair the participant's ability to comply with study procedures. * Have been diagnosed with Type 1 or Type 2 diabetes mellitus. * Have a history of chronic medical conditions involving the heart, liver, or kidneys. * Have a history of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * Have a history or presence of a gastrointestinal (GI) disorder or previous surgery that impacts gastric emptying. * Have had or plan to have during the study, a device-based or surgical treatment use for obesity. * Have been treated, or plan to be treated, with prescription medications or other non approved drugs intended to promote weight loss, within 3 months prior to screening. * Are currently enrolled or have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. * Have previously completed or withdrawn from this study or have previously received macupatide or eloralintide. * Have evidence of acute or chronic liver disease or pancreatic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | End of Study (Week 25) |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Macupatide | Baseline through Week 25 |
| PK: AUC of Macupatide in Combination with Eloralintide | Baseline through Week 25 |
| PK: Maximum Concentration (Cmax) of Macupatide | Baseline through Week 25 |
| PK: Cmax of Macupatide in Combination with Eloralintide | Baseline through Week 25 |
| Percent Change in Body Weight | Baseline through Week 25 |
Countries
Japan
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