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OpenTrials
Completed

NCT Number: NCT06132126

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

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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Key information

Conditions

Healthy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel ACT, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3938577

Drug

Administered SC.

Placebo

Drug

Administered SC.

insulin degludec

Drug

Administered SC.

Primary outcomes

  1. 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.

  2. 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.

  3. Part A: Incidence of Hypoglycemia

    Time frame: Baseline up to 16 days

  4. Part B: Incidence of Hypoglycemia

    Time frame: Baseline up to 44 days

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

    Time frame: Baseline up to 16 days

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

    Time frame: Baseline up to 44 days

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

    Time frame: Baseline up to 16 days

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

    Time frame: Baseline up to 44 days

Secondary outcomes

  1. Part A and Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC)

    Time frame: Part A: Predose up to 16 Days and Part B: Predose up to 44 Days

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2023
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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