A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62

• Status: Active, not recruiting
• Trial end date: 2022-07-08
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sparrow Pharmaceuticals
• Treatments: Anti-Inflammatory Agents; Cortisone; Glucocorticoids

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.