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A Study of LY3305677 in Healthy Participants

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Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: LY3305677
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02972645
16350
I8P-MC-OXAA (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it.

This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it.

This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).

Participation in this study is expected to last up to 16 weeks.

Enrollment

66 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Overtly healthy as determined by medical history and physical examination
  • Male participants: will agree to use a reliable method of birth control and will not donate sperm during the study and for at least 3 months following the last dose of the investigational product
  • Female participants: women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
  • First generation Japanese participants or non-Japanese participants
  • Have a body weight of more than 50 kilograms (kg)

Exclusion criteria

  • Have participated within the last 3 months in a clinical trial involving an investigational product
  • Have known allergies to glucagon-like peptide-1 (GLP-1) analogs, or any components of the formulation, or history of significant atopy
  • Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or Day -1
  • Have undergone any form of bariatric surgery
  • Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
  • Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase
  • Show evidence of human immunodeficiency virus (HIV) or Hepatitis B or C
  • Have used or intend to use medications that promote weight loss
  • Have donated blood of more than 500 milliliter (mL) within the last month
  • Currently smoke more than 10 cigarettes per day

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

66 participants in 2 patient groups, including a placebo group

LY3305677
Experimental group
Description:
Single escalating doses of LY3305677 administered subcutaneously (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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