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Completed

NCT Number: NCT05407961

A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and will last approximately 16 weeks excluding screening period for each part, respectively.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with type 2 diabetes mellitus (T2DM) for at least 3 months before screening
  • Have the following glycosylated hemoglobin (HbA1c) levels at screening:
  • HbA1c >/= 7.0% to </= 10.0% for participants treated with diet and exercise alone and participants treated with metformin alone, and
  • HbA1c >/= 6.0% to </= 9.5% for participants treated with dipeptidyl peptidase inhibitor-4 (DPP-4) (with/without metformin) inhibitors and participants treated with metformin and sodium-glucose cotransporter-2 (SGLT-2) inhibitor
  • Participants treated with diet and exercise alone or on a stable dose of metformin for at least 3 months
  • Participants with body weight up to 150 kilograms (kg) and body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m²)
  • Male participants who agree to use effective methods of contraception and female participants not of childbearing potential

Exclusion criteria

  • Participants who have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
  • Have a clinically significant abnormality ECG
  • Have obesity induced by other endocrine disorders such as Cushing's syndrome or Prader-Willi syndrome
  • Are on any glucose-lowering medications other than metformin, SGLT-2 inhibitors and/or DPP4
  • Have received chronic systemic glucocorticoid therapy (>2 weeks) in the past 6 months
  • Have an average weekly alcohol intake that exceeds 21 units per week (males 65 years of age or lesser) and 14 units per week (females and males 65 years of age or older)
  • Smoke more than 10 cigarettes, or cigarette equivalent, per day

Treatment and study plan

LY3532226

Drug

Administered SC.

Placebo

Drug

Administered SC.

Dulaglutide

Drug

Administered SC.

Other names: Trulicity

Primary outcomes

  1. Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline up to Week 16

    A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module

  2. Part B: Change from Baseline in Total Clamp Disposition Index (cDI)

    Time frame: Baseline up to Week 12

    Change from Baseline in Total cDI

Secondary outcomes

  1. Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226

    Time frame: Predose on Day 1 through Week 16

    PK: Cmax of LY3532226

  2. Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226

    Time frame: Predose on Day 1 through Week 16

    PK: AUC of LY3532226

  3. Part B: Change from Baseline in Insulin Secretion Rate (ISR) from hyperglycaemic clamp

    Time frame: Baseline through Week 12

    Change from Baseline in ISR from hyperglycaemic clamp

  4. Part B: Change from Baseline in β-cell Glucose Sensitivity (GS) from hyperglycaemic clamp

    Time frame: Baseline through Week 12

    Change from Baseline in β-cell GS from hyperglycaemic clamp

  5. Part B: Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value

    Time frame: Baseline through Week 12

    Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value

  6. Part A & B: Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT)

    Time frame: Baseline through Week 16

    Change from Baseline in Fasting and Post meal Glucose during sMMTT

  7. Part A & B: Change from Baseline in Glycosylated Haemoglobin (HbA1c)

    Time frame: Baseline through Week 16

    Change from Baseline in HbA1c

  8. Part A & B: Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT

    Time frame: Baseline through Week 16

    Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1b, 2-Part, Investigator- and Participant-Blind, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3532226 in Participants With Type 2 Diabetes Mellitus

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2022
Registry last updated
Mar 29, 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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