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A Study of LY3084077 in Healthy Participants

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Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo
Drug: LY3084077

Study type

Interventional

Funder types

Industry

Identifiers

NCT01846702
I6P-MC-FMRA (Other Identifier)
14530

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3084077 in healthy participants. The study will also investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study is expected to last approximately 8 weeks for each participant.

Enrollment

43 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Have normal blood pressure
  • Must be a healthy male or female who cannot become pregnant
  • Have a body mass index (BMI) of 18.5 to 40.0 kg/m^2, inclusive, at screening

Exclusion criteria

  • Have known allergies to fibroblast growth factor-21 (FGF21) analogues, glucagon-like peptide-1 (GLP1), GLP1-analogues or other related compounds
  • Have previous exposure to FGF21 analogues or GLP1 analogues
  • Have received live vaccine(s) within 1 month of screening, or intend to during the study
  • Have previously completed or withdrawn from this study
  • Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that in the opinion of the doctor, could make it unsafe to participate, or interfere with understanding the results of the study
  • Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing
  • Have problems with the immune system, due to a disease or treatment
  • Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia syndrome type 2
  • Have a history of pancreatitis

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

43 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Single dose of placebo matching LY3084077 administered subcutaneously (SC).
Treatment:
Drug: Placebo
LY3084077
Experimental group
Description:
Single escalating doses (1 mg up to 300 mg) of LY3084077 administered SC.
Treatment:
Drug: LY3084077

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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