A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Placebo; Drug: LY3532226

• Registration Number: NCT05887999
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-06-05
• Study Start: 2023-06-12
• Primary Completion: 2024-02-21
• Study Completion: 2024-02-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
LY3532226	LY3532226	-

Primary Outcome Measures

Name	Time	Method
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	Predose up to 120 mins postdose	PD: AUC60-120min of plasma glucagon during the insulin-induced hypoglycemia

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT)	Predose up to 120 mins postdose	Change from Baseline in Fasting and Post meal Glucose during sMMTT
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.	Predose up to 120 mins postdose	The amount of exogenous glucose infused to maintain a plasma glucose level of \>2.5 mmol/L, after the insulin infusion is terminated.
Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT	Predose up to 120 mins postdose	Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT

Trial Locations

Locations (1)

ProSciento, Inc; 🇺🇸 Chula Vista, California, United States