A Single-Site, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Glucodynamic Effects of LY3192767 in Healthy Subjects
| Registry | NCT03025009 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: double, basic science |
| Enrollment | 57 (Actual) |
| Sponsor | Eli Lilly and Company (Industry) |
| Conditions | Healthy |
| Interventions | LY3192767, Basal Insulin Peglispro, Insulin Glargine, Placebo (Drug) |
| Dates | start 2017-03-06, primary completion 2018-04-11, completion 2018-04-11, first posted 2017-01-19, last updated 2019-04-05 |
| Locations | 1 site in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of LY3192767 All trials of Basal Insulin Peglispro
The main purpose of this study is to investigate the side effects related to LY3192767 when given as an injection under the skin to healthy participants. Blood tests will be done to check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and Part B. Each participant will enroll in one part. For each participant, Part A will last up to about 32 days after last dose and Part B will last up to about 49 days after last dose. Screening must be completed prior to study start.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| LY3192767 (Part A) | Experimental | Drug: LY3192767 | Escalating doses of LY3192767 administered subcutaneously (SC). |
| Placebo (Part A) | Placebo comparator | Drug: Placebo | Placebo matching LY3192767 administered subcutaneously (SC). |
| LY3192767 (Part B) | Experimental | Drug: LY3192767 | LY3192767 administered as a SC injection in one of three study periods. |
| Basal Insulin Peglispro (Part B) | Active comparator | Drug: Basal Insulin Peglispro | Basal insulin peglispro administered as a SC injection in one of three study periods. |
| Insulin Glargine (Part B) | Active comparator | Drug: Insulin Glargine | Insulin glargine administered as a SC injection in one of three study periods. |
Sex: All, ages: 20 Years to 64 Years, accepts healthy volunteers
Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination * Have a body mass index (BMI) of >18.5 and <30.0 kilogram per square meter (kg/m²), inclusive Exclusion Criteria: * Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study * Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed * Have participated as a participant in a first-in-human study within 90 days of the initial dose of study drug * Have known allergies to insulin, heparin, or related drugs, or history of relevant allergic reactions of any origin * Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, chronic inflammatory disease, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
| Facility | City | Country | Status |
|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Neuss, North Rhine-Westphalia | Germany |
NIH grants: 2016