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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy; Type 2 Diabetes Mellitus

Treatments: Drug: LY3938577; Drug: Insulin degludec; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06132126

18779

J4P-MC-IYAA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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66 participants in 5 patient groups, including a placebo group

LY3938577 (Part A)

Experimental group

Description:

LY3938577 administered Subcutaneously (SC).

Treatment:

Drug: LY3938577

Placebo (Part A)

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo

Insulin degludec (Part A)

Active Comparator group

Description:

Insulin degludec administered SC.

Treatment:

Drug: Insulin degludec

LY3938577 (Part B)

Experimental group

Description:

LY3938577 administered SC.

Treatment:

Drug: LY3938577

Insulin degludec (Part B)

Active Comparator group

Description:

Insulin degludec administered SC.

Treatment:

Drug: Insulin degludec