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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2024-06-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3938577 (Part A)

LY3938577 administered Subcutaneously (SC).

Group Type EXPERIMENTAL

LY3938577

Intervention Type DRUG

Administered SC.

Placebo (Part A)

Placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

Insulin degludec (Part A)

Insulin degludec administered SC.

Group Type ACTIVE_COMPARATOR

Insulin degludec

Intervention Type DRUG

Administered SC.

LY3938577 (Part B)

LY3938577 administered SC.

Group Type EXPERIMENTAL

LY3938577

Intervention Type DRUG

Administered SC.

Insulin degludec (Part B)

Insulin degludec administered SC.

Group Type ACTIVE_COMPARATOR

Insulin degludec

Intervention Type DRUG

Administered SC.

Interventions

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LY3938577

Administered SC.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

Insulin degludec

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes