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A Study of Multiple Doses of LY3305677 in Healthy Participants

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Lilly

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: LY3305677
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03325387
16619
I8P-MC-OXAB (Other Identifier)

Details and patient eligibility

About

The purposes of this study are to determine:

  • The safety of LY3305677 and any side effects that might be associated with it.
  • How much LY3305677 gets into the bloodstream and how long it takes the body to remove it in healthy participants, including those of Japanese origin.
  • The effect LY3305677 has on the body, particularly the effect on blood glucose levels.

This study will last approximately 17 weeks not including screening. Screening is required within 4 weeks prior to start of the study.

This study is for research purposes only and is not intended to treat any medical conditions.

Enrollment

56 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • Women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
  • Are first-generation Japanese or non-Japanese. First-generation Japanese is defined as the participant, the participant's biological parents, and all of the participant's grandparents are of exclusive Japanese descent and have been born in Japan
  • Have a body weight of more than 54 kilograms (kg)

Exclusion criteria

  • Currently enrolled in a clinical study or have participated in a study within the past 3 months
  • Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
  • Have history of pancreatitis
  • Have known or ongoing psychiatric disorders
  • Have undergone bariatric surgery or have used any drugs for weight loss
  • Have a history of alcoholism
  • Currently smoke more than 10 cigarettes a day

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 2 patient groups, including a placebo group

LY3305677
Experimental group
Description:
Escalating doses of LY3305677 administered by subcutaneous (SC) injection
Treatment:
Drug: LY3305677
Placebo
Placebo Comparator group
Description:
Saline solution administered by SC injection
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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