A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05407961
• Other study ID #: 17835
• Secondary ID: 2021-003257-31J2
• Status: Completed
• Phase: Phase 1
• Start date: June 7, 2022
• Est. completion date: January 12, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 12, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

1. HbA1c >/= 7.0% to </= 10.0% for participants treated with diet and exercise alone and participants treated with metformin alone, and

2. 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3532226
Administered SC.
• Placebo
Administered SC.
• Dulaglutide
Administered SC.

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module	Baseline up to Week 16
Primary	Part B: Change from Baseline in Total Clamp Disposition Index (cDI)	Change from Baseline in Total cDI	Baseline up to Week 12
Secondary	Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226	PK: Cmax of LY3532226	Predose on Day 1 through Week 16
Secondary	Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226	PK: AUC of LY3532226	Predose on Day 1 through Week 16
Secondary	Part B: Change from Baseline in Insulin Secretion Rate (ISR) from hyperglycaemic clamp	Change from Baseline in ISR from hyperglycaemic clamp	Baseline through Week 12
Secondary	Part B: Change from Baseline in ß-cell Glucose Sensitivity (GS) from hyperglycaemic clamp	Change from Baseline in ß-cell GS from hyperglycaemic clamp	Baseline through Week 12
Secondary	Part B: Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value	Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value	Baseline through Week 12
Secondary	Part A & B: Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT)	Change from Baseline in Fasting and Post meal Glucose during sMMTT	Baseline through Week 16
Secondary	Part A & B: Change from Baseline in Glycosylated Haemoglobin (HbA1c)	Change from Baseline in HbA1c	Baseline through Week 16
Secondary	Part A & B: Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT	Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT	Baseline through Week 16