DRUG
LY3305677
Administered SC
Status
Completed
Phase
Phase 1
Enrollment
24
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Apr 26, 2019
Study start
Oct 27, 2019
Primary completion
Jul 8, 2021
Study completion
Jul 8, 2021
Results posted
Not reported
Registry updated
Jul 19, 2021
Outcomes
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Time frame · Baseline through 24 weeks
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3305677
Time frame · Baseline through 48 hours postdose
PK: Cmax of LY3305677
PK: Area Under the Concentration-Time Curve (AUC) of LY3305677
Time frame · Baseline through 48 hours postdose
PK: AUC of LY3305677
Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
Time frame · Baseline, through Week 16
PD: Change from Baseline in Fasting Plasma Glucose
PD: Change from Baseline in Fasting Plasma Insulin
Time frame · Baseline, through Week 16
PD: Change from Baseline in Fasting Plasma Insulin
Eligibility
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)
Study locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
Profil Institut für Stoffwechselforschung
Neuss, North Rhine-Westphalia, Germany
Publications
No PMID-linked publications were present in this registry snapshot.
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