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A Study of LY3305677 in Participants With Type 2 Diabetes

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Lilly

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo
Drug: LY3305677

Study type

Interventional

Funder types

Industry

Identifiers

NCT03928379
2018-004779-11 (EudraCT Number)
I8P-MC-OXAD (Other Identifier)
17011

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

20 to 69 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

24 participants in 2 patient groups, including a placebo group

LY3305677
Experimental group
Description:
LY3305677 administered SC
Treatment:
Drug: LY3305677
Placebo
Placebo Comparator group
Description:
Placebo administered SC
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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