A Study of LY3493269 in Participants With Type 2 Diabetes

Phase 1

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
1.5 milligrams (mg) Dulaglutide	Dulaglutide	Participants received 1.5 mg dulaglutide subcutaneously (SC) once weekly (QW) for 4 weeks.
0.3 mg LY3493269	LY3493269	Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
1 mg LY3493269	LY3493269	Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.
0.75/1.5/3 mg LY3493269	LY3493269	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.
1.5/3/4/5 mg LY3493269	LY3493269	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.
Placebo	Placebo	Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

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

Locations (3): Miami Research Associates
🇺🇸
Miami, Florida, United States
Clinical Trials of Texas, Inc.
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San Antonio, Texas, United States
Anaheim Clinical Trials, LLC
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Anaheim, California, United States