A Study of LY3493269 in Participants With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Subcutaneous Doses of LY3493269 in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515576
• Other study ID #: 17530
• Secondary ID: J1X-MC-GZHC
• Status: Completed
• Phase: Phase 1
• Start date: August 25, 2020
• Est. completion date: March 9, 2021

Study information

• Verified date: April 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to determine the side effects related to LY3493269 in participants with type 2 diabetes. Blood tests will be performed to check concentrations of LY3493269 in the bloodstream. Each enrolled participant will receive LY3493269, dulaglutide, or placebo. The study will last up to approximately 16 weeks for each participant and may include up to 11 visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 9, 2021
• Est. primary completion date: March 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Are male or female not of childbearing potential

• Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening

• Have had a stable body weight (<5% body weight change) for the 3 months prior to screening

• Have not modified their diet or adopted any nutritional lifestyle modification in the 3 months prior to screening

• Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are on a stable dose of metformin for at least 3 months before screening. Patients with comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) may be eligible for inclusion if conditions are assessed by the investigator to be well controlled and stable for at least 3 months prior to screening

• Have an HbA1c of at least 7.0% and no more than 10.5% at screening

• Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator

Exclusion Criteria:

• Have type 1 diabetes mellitus or latent autoimmune diabetes in adults

• Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening

• Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment

• Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.

• Have a definitive diagnosis of autonomic neuropathy as evidenced by urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea

• Have a history of acute or chronic pancreatitis

• Have a self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma

• Have calcitonin levels of 20 picograms per millilitre (pg/mL) or more at screening

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3493269
Administered SC
• Dulaglutide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Miami Research Associates	Miami	Florida
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through final follow-up at Day 57
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3493269	PK: AUC of LY3493269	Baseline through final follow-up at Day 57
Secondary	PK: Maximum Concentration (Cmax) of LY3493269	PK: Cmax of LY3493269	Baseline through final follow-up at Day 57
Secondary	Pharmacodynamics (PD):Change from baseline to Day 29 in Fasting Glucose (FG)		Baseline, Day 29

External Links

•   A Study of LY3493269 in Participants With Type 2 Diabetes