A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

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.

Official Title
-----------------
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

Conditions
-----------------
Healthy, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: LY3938577
* Drug: Placebo
* Drug: Insulin degludec


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3938577 (Part A)<br>LY3938577 administered Subcutaneously (SC). | Drug: LY3938577<br>* Administered SC.<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo administered SC. | Drug: Placebo<br>* Administered SC.<br>|
| Active Comparator: Insulin degludec (Part A)<br>Insulin degludec administered SC. | Drug: Insulin degludec<br>* Administered SC.<br>|
| Experimental: LY3938577 (Part B)<br>LY3938577 administered SC. | Drug: LY3938577<br>* Administered SC.<br>|
| Active Comparator: Insulin degludec (Part B)<br>Insulin degludec administered SC. | Drug: Insulin degludec<br>* Administered SC.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | 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 | A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Baseline up to 44 days | 
| 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 | 
| Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters |  | Baseline up to 44 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |