A Study of LY3305677 in Participants With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multiple-Ascending Dose Study in Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928379
• Other study ID #: 17011
• Secondary ID: I8P-MC-OXAD2018-
• Status: Completed
• Phase: Phase 1
• Start date: October 27, 2019
• Est. completion date: July 8, 2021

Study information

• Verified date: July 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 8, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 69 Years

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3305677
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung	Neuss	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through 24 weeks
Secondary	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3305677	PK: Cmax of LY3305677	Baseline through 48 hours postdose
Secondary	PK: Area Under the Concentration-Time Curve (AUC) of LY3305677	PK: AUC of LY3305677	Baseline through 48 hours postdose
Secondary	Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose	PD: Change from Baseline in Fasting Plasma Glucose	Baseline, through Week 16
Secondary	PD: Change from Baseline in Fasting Plasma Insulin	PD: Change from Baseline in Fasting Plasma Insulin	Baseline, through Week 16