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A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status

Active

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

LY3532226

Placebo

Dulaglutide

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Profil Institut für Stoffwechselforschung

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Experimental

Arm Label

LY3532226 + Dulaglutide (Part A)

Placebo + Dulaglutide (Part A)

Dulaglutide + Placebo (Part B)

LY3532226 + Dulaglutide (Part B)

LY3532226 + Placebo (Part B)

Arm Description

LY3532226 administered subcutaneously (SC) followed by dulaglutide administered SC.

Placebo administered SC followed by dulaglutide administered SC.

Dulaglutide administered SC in combination with placebo given SC.

LY3532226 administered SC in combination with Dulaglutide given SC.

LY3532226 administered SC in combination with placebo given SC.

Outcomes

Primary Outcome Measures

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

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

Change from Baseline in Total cDI

Secondary Outcome Measures

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

PK: Cmax of LY3532226

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

PK: AUC of LY3532226

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

Change from Baseline in ISR from hyperglycaemic clamp

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

Change from Baseline in β-cell GS from hyperglycaemic clamp

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

Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value

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

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

Change from Baseline in HbA1c

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

Full Information

NCT ID

NCT05407961

First Posted

May 26, 2022

Last Updated

October 19, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT05407961

Brief Title

A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 15, 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 7, 2022 (Actual)

Primary Completion Date

December 24, 2023 (Anticipated)

Study Completion Date

January 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LY3532226 + Dulaglutide (Part A)

Arm Type

Experimental

Arm Description

LY3532226 administered subcutaneously (SC) followed by dulaglutide administered SC.

Arm Title

Placebo + Dulaglutide (Part A)

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC followed by dulaglutide administered SC.

Arm Title

Dulaglutide + Placebo (Part B)

Arm Type

Active Comparator

Arm Description

Dulaglutide administered SC in combination with placebo given SC.

Arm Title

LY3532226 + Dulaglutide (Part B)

Arm Type

Experimental

Arm Description

LY3532226 administered SC in combination with Dulaglutide given SC.

Arm Title

LY3532226 + Placebo (Part B)

Arm Type

Experimental

Arm Description

LY3532226 administered SC in combination with placebo given SC.

Intervention Type

Drug

Intervention Name(s)

LY3532226

Intervention Description

Administered SC.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC.

Intervention Type

Drug

Intervention Name(s)

Dulaglutide

Other Intervention Name(s)

Trulicity

Intervention Description

Administered SC.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline up to Week 16

Title

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

Description

Change from Baseline in Total cDI

Time Frame

Baseline up to Week 12

Secondary Outcome Measure Information:

Title

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

Description

PK: Cmax of LY3532226

Time Frame

Predose on Day 1 through Week 16

Title

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

Description

PK: AUC of LY3532226

Time Frame

Predose on Day 1 through Week 16

Title

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

Description

Change from Baseline in ISR from hyperglycaemic clamp

Time Frame

Baseline through Week 12

Title

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

Description

Change from Baseline in β-cell GS from hyperglycaemic clamp

Time Frame

Baseline through Week 12

Title

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

Description

Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value

Time Frame

Baseline through Week 12

Title

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

Description

Change from Baseline in Fasting and Post meal Glucose during sMMTT

Time Frame

Baseline through Week 16

Title

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

Description

Change from Baseline in HbA1c

Time Frame

Baseline through Week 16

Title

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

Description

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

Time Frame

Baseline through Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Profil Institut für Stoffwechselforschung

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

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