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:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT05857566
Eligibility Criteria:
Inclusion Criteria:
* A glycated hemoglobin (HbA1c) level of \<5.7% at Screening
* A 12-lead electrocardiogram (ECG) at Screening which, in the opinion of the Investigator, had no abnormalities that compromised safety in this study
* Hematology, clinical chemistry and urinalysis at Screening, the results of which fall within normal parameter ranges and/or are deemed clinically acceptable by the Investigator Exclusion Criteria
* Males and nonpregnant, nonlactating females
Exclusion Criteria:
* Any prior use of or contraindication to atypical antipsychotics
* Concomitant use of drugs known to impact the PK of olanzapine
* Type 1 or Type 2 diabetes
* Recent CV event
* Uncontrolled hypertension
* Fasting triglycerides ≥400 mg/dL
* Fasting glucose ≥100 mg/dL
* Any condition that impacts the absorption of dietary fats
* Significant gastrointestinal disorders
* Gall bladder disease
* Uncontrolled hypothyroidism
* Liver disease or dysfunction
* Renal disease or dysfunction
* Gastrointestinal conditions
* Hematologic disorders
* Active malignancy
* Psychiatric disorder
* History of drug or alcohol abuse
* Pregnant, breastfeeding, or intending to become pregnant
* Use of weight loss products
* Blood donation or loss within 30 days prior to Screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05857566
Study Brief:
Protocol Section:
NCT05857566