A Study of LY3493269 in Participants With Type 2 Diabetes

NCT04515576 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17530J1X-MC-GZHC
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

  TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that, at any dose: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Other situations: Based on medical or scientific judgement. 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 Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269

  Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.

• PK: Maximum Observed Drug Concentration (Cmax) of LY3493269

  Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.

• Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose

  Baseline, Day 29

Study Arms (6)

1.5 milligrams (mg) Dulaglutide

ACTIVE COMPARATOR

Participants received 1.5 mg dulaglutide subcutaneously (SC) once weekly (QW) for 4 weeks.

Drug: Dulaglutide

0.3 mg LY3493269

EXPERIMENTAL

Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.

Drug: LY3493269

1 mg LY3493269

EXPERIMENTAL

Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.

Drug: LY3493269

0.75/1.5/3 mg LY3493269

EXPERIMENTAL

Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.

Drug: LY3493269

1.5/3/4/5 mg LY3493269

EXPERIMENTAL

Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.

Drug: LY3493269

Placebo

PLACEBO COMPARATOR

Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.

Drug: Placebo

Interventions

LY3493269 DRUG

Administered SC

0.3 mg LY3493269; 0.75/1.5/3 mg LY3493269; 1 mg LY3493269; 1.5/3/4/5 mg LY3493269

Dulaglutide DRUG

Administered SC

Also known as: LY2189265

1.5 milligrams (mg) Dulaglutide

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:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Related Links

• A Study of LY3493269 in Participants With Type 2 Diabetes

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 17, 2020
• Study Start: August 25, 2020
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2021
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)