A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

A Phase 1, Randomized, Placebo-Controlled, 2-Period, Cross-over, Double- Blind, Single-Dose Study to Evaluate the Effects of LY3532226 on Insulin- Induced Hypoglycemia in Participants With Type 1 Diabetes Mellitus

The main purpose of this study is to evaluate the response of glucagon to insulin-induced low blood sugar after administration of the study drug LY3532226 in participants with type 1 diabetes mellitus (T1DM). The study will also evaluate if LY3532226 helped participants to recover from insulin-induced low blood sugar condition compared to placebo. The study will last approximately 16 weeks excluding screening period.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Placebo; Drug: LY3532226

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • ProSciento, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with type 1 diabetes mellitus (T1DM) for at least 2 years treated with insulin
• Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
• Are males or females not of childbearing potential

Exclusion Criteria:

• Have acute proliferative retinopathy requiring active treatment within 3 months of screening
• Have been treated with dipeptidyl peptidase-Ni, GLP-1 receptor agonists, GIP agonists, metformin or sodium-glucose cotransporter 2 inhibitors within the previous 3 months
• Have received systemic or inhaled glucocorticoid therapy
• Women of childbearing potential
• Are currently taking part in another clinical study trial involving medical research, or have participated within the last 30 days of screening in a clinical study involving a study intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Administered SC.
Experimental: LY3532226	Drug: LY3532226; Administered subcutaneously (SC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics (PD): Area under the concentration versus time curve from time 60 to 120 minutes (AUC60-120min) of plasma glucagon during the insulin-induced hypoglycemia	PD: AUC60-120min of plasma glucagon during the insulin-induced hypoglycemia	Predose up to 120 mins postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of exogenous glucose infused to maintain a plasma glucose level of >2.5 millimole per liter (mmol/L), after the insulin infusion is terminated.	The amount of exogenous glucose infused to maintain a plasma glucose level of >2.5 mmol/L, after the insulin infusion is terminated.	Predose up to 120 mins postdose
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	Predose up to 120 mins postdose
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	Predose up to 120 mins postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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

Publications and helpful links

Helpful Links

• A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Actual): February 21, 2024
• Study Completion (Actual): February 21, 2024

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 18064; J2V-MC-GZLC (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No