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

NCT06132126 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18779J4P-MC-IYAA
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• 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

Study Arms (5)

LY3938577 (Part A)

EXPERIMENTAL

LY3938577 administered Subcutaneously (SC).

Drug: LY3938577

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Insulin degludec (Part A)

ACTIVE COMPARATOR

Insulin degludec administered SC.

Drug: Insulin degludec

LY3938577 (Part B)

EXPERIMENTAL

LY3938577 administered SC.

Drug: LY3938577

Insulin degludec (Part B)

ACTIVE COMPARATOR

Insulin degludec administered SC.

Drug: Insulin degludec

Interventions

LY3938577 DRUG

Administered SC.

LY3938577 (Part A); LY3938577 (Part B)

Placebo DRUG

Administered SC.

Placebo (Part A)

Insulin degludec DRUG

Administered SC.

Insulin degludec (Part A); Insulin degludec (Part B)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

CenExel ACT

Anaheim, California, 92801, United States

Location

Qps-Mra, Llc

Miami, Florida, 33143, United States

Location

Labcorp CRU

Dallas, Texas, 75247, United States

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: November 17, 2023
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)