Skip to main content
OpenTrials
Completed

NCT Number: NCT03928379

A Study of LY3305677 in Participants With Type 2 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LY3305677

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

  1. 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

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3305677

    Time frame: Baseline through 48 hours postdose

    PK: Cmax of LY3305677

  2. PK: Area Under the Concentration-Time Curve (AUC) of LY3305677

    Time frame: Baseline through 48 hours postdose

    PK: AUC of LY3305677

  3. Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose

    Time frame: Baseline, through Week 16

    PD: Change from Baseline in Fasting Plasma Glucose

  4. PD: Change from Baseline in Fasting Plasma Insulin

    Time frame: Baseline, through Week 16

    PD: Change from Baseline in Fasting Plasma Insulin

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2019
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.