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

Eli Lilly and Company66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Type 2 Diabetes Mellitus

Interventions

LY3938577DRUG

Administered SC.

PlaceboDRUG

Administered SC.

Insulin degludecDRUG

Administered SC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

CenExel ACT

Anaheim, California, United States

Qps-Mra, Llc

Miami, Florida, United States

Labcorp CRU

Dallas, Texas, United States

Outcomes

Primary Outcomes

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.

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

A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Time frame: Baseline up to 44 days

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 A: Number of Participants With Clinically Significant Changes in Vital Signs

Time frame: Baseline up to 16 days

Part B: Number of Participants With Clinically Significant Changes in Vital Signs

Time frame: Baseline up to 44 days

Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters

Time frame: Baseline up to 16 days

Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters

Time frame: Baseline up to 44 days

Secondary Outcomes

Data from ClinicalTrials.gov

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