A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

NCT05887999 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18064J2V-MC-GZLC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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 Glucagon Concentration at Fasting and Post meal during sMMTT

  Predose up to 120 mins postdose

Study Arms (2)

LY3532226

EXPERIMENTAL

Drug: LY3532226

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LY3532226 DRUG

Administered subcutaneously (SC).

LY3532226

Placebo DRUG

Administered SC.

Placebo

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

ProSciento, Inc

Chula Vista, California, 91911, United States

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune 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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 5, 2023
• Study Start: June 12, 2023
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)