Phase 1 Completed N=56 Randomized Double-blind Basic Science

A Study of LY3493269 in Participants With Type 2 Diabetes

Source: ClinicalTrials.gov NCT04515576 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcomePrimary: 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 — 0; 0; 0; 0 Participants

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.

Outcome Measures

Outcome	Result	p-value
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	0; 0; 0; 0; 0; 0	—
SECONDARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269	4220; 18500; 10200; 22800; 10600; 38500	—
SECONDARY PK: Maximum Observed Drug Concentration (Cmax) of LY3493269	31.2; 153; 73.6; 165; 80.3; 287	—
SECONDARY Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose	-1.07; -4.11; -2.20; -4.83; -3.61; -3.98	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04515576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.