Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT01846702
Eligibility Criteria:
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* Have previously completed or withdrawn from this study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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01846702
Study Brief:
Protocol Section:
NCT01846702