A Study of LY3305677 in Participants With Type 2 Diabetes

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: LY3305677

• Registration Number: NCT03928379
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-26
• Study Start: 2019-10-27
• Status Verified: 2021-07
• Primary Completion: 2021-07-08
• Study Completion: 2021-07-08
• Last Update Submitted: 2021-07-16
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered SC
LY3305677	LY3305677	LY3305677 administered SC

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug	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

Secondary Outcome Measures

Name	Time	Method
PK: Area Under the Concentration-Time Curve (AUC) of LY3305677	Baseline through 48 hours postdose	PK: AUC of LY3305677
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3305677	Baseline through 48 hours postdose	PK: Cmax of LY3305677
Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose	Baseline, through Week 16	PD: Change from Baseline in Fasting Plasma Glucose
PD: Change from Baseline in Fasting Plasma Insulin	Baseline, through Week 16	PD: Change from Baseline in Fasting Plasma Insulin

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung; 🇩🇪 Neuss, Nordrhein-Westfalen, Germany