Status:
COMPLETED
A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62
Lead Sponsor:
Sparrow Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus in Obese
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This will be an exploratory, open-label study of 11β-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibition by SPI-62 in obese subjects with type 2 diabetes mellitus (T2DM)
Detailed Description
The main objective of the study is to characterize the relationship between SPI-62 plasma concentration and adipose tissue inhibition of HSD-1 in obese subjects with T2DM.Additional objectives of the ...
Eligibility Criteria
Inclusion
- Male or non-menstruating female
- 18 to 65 years of age
- BMI 30.0 to 45.0 kg/m2
- Diagnosis of T2DM for at least 3 months prior to the first dose of study drug.
Exclusion
- Uncontrolled T2DM with glycated hemoglobin ≥9.5%.
- Any other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results.
- Any clinically significant abnormal laboratory value which cannot be explained by a known and permitted clinical condition.
- Positive urine drug screen (except tetrahydrocannabinol) or positive alcohol breath test result.
- Participation in a clinical trial involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives, whichever is longer, or 90 days for a biological, prior to the first dose of study drug.
- Use of, or intent to use, any medications/products (prescription or over-the-counter) or herbal supplements within 4 weeks prior to the first dose of study drug, except those specifically allowed in the protocol.
Key Trial Info
Start Date :
July 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05409027
Start Date
July 23 2021
End Date
February 7 2024
Last Update
April 22 2024
Active Locations (1)
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1
ProSciento
Chula Vista, California, United States, 91911