A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

NCT ID: NCT05887999

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2024-02-21

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3532226

Group Type EXPERIMENTAL

LY3532226

Intervention Type DRUG

Administered subcutaneously (SC).

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

Interventions

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LY3532226

Administered subcutaneously (SC).

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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ProSciento, Inc

Chula Vista, California, United States

Site Status

Countries

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United States

Related Links

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https://trials.lilly.com/en-US/trial/407539

A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus

Other Identifiers

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J2V-MC-GZLC

Identifier Type: OTHER

Identifier Source: secondary_id

18064

Identifier Type: -

Identifier Source: org_study_id

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