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

NCT05409027 | Completed Phase 1 FDA Drug

• 1 other identifier: SPI-62-CL-1001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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)

Conditions

Type 2 Diabetes Mellitus in Obese; Obesity; Type2Diabetes

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (Cmax)

  Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Observed Maximum Plasma Concentration (Cmax)

  Days 1 through 14

Secondary Outcomes (4)

• Pharmacokinetics (tmax)

  Days 1 through 14

• Pharmacokinetics (AUC0-t)

  Days 1 through 14

• Cortisone-d8 concentrations

  Days 1 through 14

• Urinary HSD-1 Ratio

  Days -1 to 15

Study Arms (1)

Single Arm

EXPERIMENTAL

Each subject will receive between 1 to 15 mg SPI-62 QD PO for up to 14 days. Each subject will receive up to 12 mcg cortisone-d8 SC during each of one or more study visits.

Drug: SPI-62; Drug: Cortisone-d8

Interventions

SPI-62 DRUG

SPI-62 is supplied as 1 mg tablets for oral dosing.

Also known as: HSD-1 inhibitor

Single Arm

Cortisone-d8 DRUG

Cortisone-d8 is supplied as a 1 mcg/mL solution for infusion

Also known as: Glucocorticoid and anti-inflammatory agent

Single Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-menstruating female
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sparrow Pharmaceuticals: lead

Study Sites (1)

ProSciento

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Glucocorticoids; Anti-Inflammatory Agents

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• David Katz, PhD

  Sparrow Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: June 7, 2022
• Study Start: July 23, 2021
• Primary Completion: March 10, 2022
• Study Completion: February 7, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)