A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05887999

Collaborator

(none)

Enrollment

Location

Arms

8.6

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Drug: LY3532226 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Jun 12, 2023

Anticipated Primary Completion Date :

Jan 8, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: LY3532226

Drug: LY3532226

Administered subcutaneously (SC).

Placebo Comparator: Placebo

Drug: Placebo

Administered SC.

Outcome Measures

Primary Outcome Measures

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

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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProSciento, Inc	Chula Vista	California	United States	91911

Sponsors and Collaborators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT05887999

Other Study ID Numbers:

18064
J2V-MC-GZLC

First Posted:

Jun 5, 2023

Last Update Posted:

Jun 5, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jun 5, 2023