A Single and Multiple-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 66
- Locations
- 3
- Primary Endpoint
- Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
LY3938577 (Part A)
LY3938577 administered Subcutaneously (SC).
Intervention: LY3938577 (Drug)
Placebo (Part A)
Placebo administered SC.
Intervention: Placebo (Drug)
Insulin degludec (Part A)
Insulin degludec administered SC.
Intervention: Insulin degludec (Drug)
LY3938577 (Part B)
LY3938577 administered SC.
Intervention: LY3938577 (Drug)
Insulin degludec (Part B)
Insulin degludec administered SC.
Intervention: Insulin degludec (Drug)
Outcomes
Primary Outcomes
Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Time Frame: Baseline up to 16 days
Part A: Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline up to 16 days
Part B: Incidence of Hypoglycemia
Time Frame: Baseline up to 44 days
Part B: Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame: Baseline up to 44 days
Secondary Outcomes
- 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)