DRUG
LY3493269
Administered SC
Status
Completed
Phase
Phase 1
Enrollment
56
Locations
3
Results
Posted
Publications
0
Study 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.
Interventions
DRUG
Administered SC
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Aug 17, 2020
Study start
Aug 25, 2020
Primary completion
Mar 9, 2021
Study completion
Mar 9, 2021
Results posted
Jan 14, 2025
Registry updated
Jan 14, 2025
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
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
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
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
No PMID-linked publications were present in this registry snapshot.
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