Current partner codePEPTIDESDE
NCT04515576·Phase 1·INTERVENTIONAL

A Study of LY3493269 in Participants With Type 2 Diabetes

Status

Completed

Phase

Phase 1

Enrollment

56

Locations

3

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

LY3493269

Administered SC

DRUG

Dulaglutide

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Aug 17, 2020

  2. Study start

    Aug 25, 2020

  3. Primary completion

    Mar 9, 2021

  4. Study completion

    Mar 9, 2021

  5. Results posted

    Jan 14, 2025

  6. Registry updated

    Jan 14, 2025

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Baseline through final follow-up at Day 57

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

Secondary outcomes

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

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

Area Under the Concentration Versus Time Curve from Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269

PK: Maximum Observed Drug Concentration (Cmax) of LY3493269

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

Maximum Observed Drug Concentration (Cmax) of LY3493269

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

Time frame · Baseline, Day 29

Pharmacodynamics (PD): Summary Statistics (Mean, Standard Deviation) of Change From Baseline to Day 29.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

3 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Miami Research Associates

Miami, Florida, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.