CClinicalTrials.gg
CompletedNCT05887999Updated Mar 26, 2024

A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

A Phase 1 interventional study of LY3532226 and Placebo in Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-26.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Feb 2024, 2 years 7 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    LY3532226

    Drug: LY3532226

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugLY3532226

    Administered subcutaneously (SC).

  • DrugPlacebo

    Administered SC.

06

What researchers measure

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

    Time frame: Predose up to 120 mins postdose

Secondary outcomes

  1. 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.

    Time frame: Predose up to 120 mins postdose

  2. 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

    Time frame: Predose up to 120 mins postdose

  3. 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

    Time frame: Predose up to 120 mins postdose

07

Study locations

1 site
  • ProSciento, Inc
    Chula Vista, California 91911, United States
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05887999
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jun 5, 2023
Start date
Jun 12, 2023
Primary completion
Feb 21, 2024
Completion
Feb 21, 2024
Last update
Mar 26, 2024

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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