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Clinical Trials/NCT06132126
NCT06132126CompletedPhase 1

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

Eli Lilly and Company3 sites in 1 country66 target enrollmentStarted: November 17, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
66
Locations
3
Primary Endpoint
Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

LY3938577 (Part A)

Experimental

LY3938577 administered Subcutaneously (SC).

Intervention: LY3938577 (Drug)

Placebo (Part A)

Placebo Comparator

Placebo administered SC.

Intervention: Placebo (Drug)

Insulin degludec (Part A)

Active Comparator

Insulin degludec administered SC.

Intervention: Insulin degludec (Drug)

LY3938577 (Part B)

Experimental

LY3938577 administered SC.

Intervention: LY3938577 (Drug)

Insulin degludec (Part B)

Active Comparator

Insulin degludec administered SC.

Intervention: Insulin degludec (Drug)

Outcomes

Primary Outcomes

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

Time Frame: Baseline up to 16 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 one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration

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

Time Frame: 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

Time Frame: 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 A: Incidence of Hypoglycemia

Time Frame: Baseline up to 16 days

Part B: Incidence of Hypoglycemia

Time Frame: Baseline up to 44 days

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

Time Frame: Baseline up to 44 days

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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