A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
Part of paid clinical trials in Anaheim, California.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT06132126
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy
- Type 2 Diabetes Mellitus
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Accepted
Interventions
- LY3938577 — DRUGAdministered SC.
- Placebo — DRUGAdministered SC.
- Insulin degludec — DRUGAdministered SC.
Study Details
The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 Diabetes Mellitus (T2DM) (Part A) and multiple doses of LY3938577 in participants with T2DM (Part B). The study will last approximately 6 weeks for Part A and approximately 10 weeks for Part B respectively.
Key Dates
- Start date
- Nov 17, 2023
- Status verified
- Jul 2024
- Primary completion
- Jun 28, 2024
- Completion
- Jun 28, 2024
Study Design
- Enrollment
- 66 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: LY3938577 (Part A)LY3938577 administered Subcutaneously (SC).
- Placebo Comparator: Placebo (Part A)Placebo administered SC.
- Active Comparator: Insulin degludec (Part A)Insulin degludec administered SC.
- Experimental: LY3938577 (Part B)LY3938577 administered SC.
- Active Comparator: Insulin degludec (Part B)Insulin degludec administered SC.
Primary Outcome Measure
Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration [ Time Frame: Baseline up to 16 days ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| CenExel ACT | Anaheim | California | 92801 | - |
| Qps-Mra, Llc | Miami | Florida | 33143 | - |
| Labcorp CRU | Dallas | Texas | 75247 | - |
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