A Study of LY3305677 in Participants With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-27

Study Completion Date

2021-07-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3305677

LY3305677 administered SC

Group Type EXPERIMENTAL

LY3305677

Intervention Type DRUG

Administered SC

Placebo

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3305677

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No