A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

NCT05407961 | Completed Phase 1 FDA Drug

• 3 other identifiers: 178352021-003257-31J2V-MC-GZLB
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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

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

  Change from Baseline in Total cDI

  Baseline up to Week 12

Secondary Outcomes (8)

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

  Predose on Day 1 through Week 16

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

  Predose on Day 1 through Week 16

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

  Baseline through Week 12

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

  Baseline through Week 12

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

  Baseline through Week 12

Study Arms (5)

LY3532226 + Dulaglutide (Part A)

EXPERIMENTAL

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

Drug: LY3532226; Drug: Dulaglutide

Placebo + Dulaglutide (Part A)

PLACEBO COMPARATOR

Placebo administered SC followed by dulaglutide administered SC.

Drug: Placebo; Drug: Dulaglutide

Dulaglutide + Placebo (Part B)

ACTIVE COMPARATOR

Dulaglutide administered SC in combination with placebo given SC.

Drug: Placebo; Drug: Dulaglutide

LY3532226 + Dulaglutide (Part B)

EXPERIMENTAL

LY3532226 administered SC in combination with Dulaglutide given SC.

Drug: LY3532226; Drug: Dulaglutide

LY3532226 + Placebo (Part B)

EXPERIMENTAL

LY3532226 administered SC in combination with placebo given SC.

Drug: LY3532226; Drug: Placebo

Interventions

LY3532226 DRUG

Administered SC.

LY3532226 + Dulaglutide (Part A); LY3532226 + Dulaglutide (Part B); LY3532226 + Placebo (Part B)

Placebo DRUG

Administered SC.

Dulaglutide + Placebo (Part B); LY3532226 + Placebo (Part B); Placebo + Dulaglutide (Part A)

Dulaglutide DRUG

Administered SC.

Also known as: Trulicity

Dulaglutide + Placebo (Part B); LY3532226 + Dulaglutide (Part A); LY3532226 + Dulaglutide (Part B); Placebo + Dulaglutide (Part A)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 7, 2022
• Study Start: June 7, 2022
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)