Clinical trial NCT03928379: A Study of LY3305677 in Participants With Type 2 Diabetes
Official title: A Multiple-Ascending Dose Study in Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-04-26
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to learn more about the safety and side effects of LY3305677 when it is given as an injection just under the skin to participants with type 2 diabetes. The study will last about 20 weeks for each participant, not including screening.


Eligibility criteria: Inclusion Criteria:

* Have Type II diabetes
* Body mass index (BMI) of 25-40 kilograms per square meter (kg/m²), inclusive
* Have a body weight of \<150 kilograms (kg)
* Have clinical lab test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator; however, should have serum magnesium and potassium levels, along with lactate dehydrogenase, CK values within the normal range at screening and Day -2.

Exclusion Criteria:

* Have Type 1 diabetes or latent autoimmune diabetes in adults
* Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization for 6 months prior to screening
* Have had an episode of severe hypoglycemia, defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 6 months prior to Visit 1
* Have an abnormal 12-lead electrocardiogram (ECG) at screening and/or Day -2 that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
* Have poorly controlled hypertension at screening; or a change in antihypertensive medication within 30 days of screening
* Have an estimated glomerular filtration rate \<45 milliliters per minute per 1.73 meters squared of body surface area (mL/min/1.73 m²)

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
timeFrame: Baseline through 24 weeks
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3305677
timeFrame: Baseline through 48 hours postdose
measure: PK: Area Under the Concentration-Time Curve (AUC) of LY3305677
timeFrame: Baseline through 48 hours postdose
measure: Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
timeFrame: Baseline, through Week 16
measure: PD: Change from Baseline in Fasting Plasma Insulin
timeFrame: Baseline, through Week 16
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung
state: Nordrhein-Westfalen
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: