Healthy, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 A: Incidence of Hypoglycemia | Baseline up to 16 days | — |
| Part B: Incidence of Hypoglycemia | Baseline up to 44 days | — |
| Part A: Number of Participants With Clinically Significant Changes in Vital Signs | Baseline up to 16 days | — |
| Part B: Number of Participants With Clinically Significant Changes in Vital Signs | Baseline up to 44 days | — |
| Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters | Baseline up to 16 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed