Skip to main content
OpenTrials
Completed

NCT Number: NCT01846702

A Study of LY3084077 in Healthy Participants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Singapore, 117597

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study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

Treatment and study plan

Placebo

Drug

Given as a SC injection.

LY3084077

Drug

Given as a SC injection.

Primary outcomes

  1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Pre-dose, Up to Day 190

    An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077

    Time frame: Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose

  2. PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077

    Time frame: Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose

  3. Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides

    Time frame: Baseline, Up to Day 15

    Percent change=(measure at time t-measure at baseline)/measure at baseline*100%). Least Square Means (LS means) were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.

  4. PD: Change From Baseline in Fasting Insulin

    Time frame: Baseline, Up to Day 15

    LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.

  5. PD: Change From Baseline in Weight

    Time frame: Baseline, Up to Day 15

  6. PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal

    Time frame: Baseline, Day 2

    LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.

  7. PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal

    Time frame: Baseline, Day 2

    LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.

  8. PD: Change From Baseline to Day 2 in Fasting Glucagon

    Time frame: Baseline, Up to Day 2

    LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.

  9. Number of Participants Developing Anti-LY3084077 Antibodies

    Time frame: Pre-dose, Up to Day 190

    The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3084077 in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 3, 2013
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.