A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes MellitusHealthy
- Interventions
- Registration Number
- NCT06132126
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- Male and female participants who are overtly healthy as determined by medical evaluation (Part A)
- Participants with T2DM diagnosed greater than 1 year before enrollment (Part A and Part B)
- Have a body mass index within the range of 18.5 to less than or equal to (<=) 32 kilograms per square meter (kg/m²) for healthy participants and 18.5 to 40 kg/m² for T2DM participants.
- Male or female participants of nonchildbearing potential
- Have proliferative retinopathy or maculopathy and/or severe neuropathy
- Have been treated with sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, glucagon-like peptide-1 receptor agonist or Insulin within the previous 3 months
- Have received chronic systemic glucocorticoid therapy in the past 3 months
- Are currently enrolled in another clinical study trial involving medical research, or have participated within the last 30 days in a clinical study involving an investigational product.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo (Part A) Placebo Placebo administered SC. LY3938577 (Part A) LY3938577 LY3938577 administered Subcutaneously (SC). LY3938577 (Part B) LY3938577 LY3938577 administered SC. Insulin degludec (Part A) Insulin degludec Insulin degludec administered SC. Insulin degludec (Part B) Insulin degludec Insulin degludec administered SC.
- Primary Outcome Measures
Name Time Method Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters Baseline up to 16 days Part A: Number of Participants With Clinically Significant Changes in Vital Signs Baseline up to 16 days Part B: 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 Baseline up to 44 days A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters Baseline up to 44 days 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 Baseline up to 16 days A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Part A: Incidence of Hypoglycemia Baseline up to 16 days Part B: Incidence of Hypoglycemia Baseline up to 44 days Part B: Number of Participants With Clinically Significant Changes in Vital Signs Baseline up to 44 days
- Secondary Outcome Measures
Name Time Method Part A and Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Part A: Predose up to 16 Days and Part B: Predose up to 44 Days
Related Research Topics
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Trial Locations
- Locations (3)
Labcorp CRU
🇺🇸Dallas, Texas, United States
Qps-Mra, Llc
🇺🇸Miami, Florida, United States
CenExel ACT
🇺🇸Anaheim, California, United States