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NCT05409027 | COMPLETED | Type 2 Diabetes Mellitus in Obese

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

Sparrow Pharmaceuticals

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)

Condition or disease

Type 2 Diabetes Mellitus in Obese

Obesity

Type2Diabetes

Intervention/treatment

SPI-62

Cortisone-d8

Phase

PHASE1

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 study are to characterize the relationship between adipose SPI-62 concentration and HSD-1 inhibition, to characterize the relationship between SPI-62 plasma concentration and liver inhibition of HSD-1, and to monitor the safety and tolerability of SPI-62, in obese subjects with T2DM. This will be a Phase I, open-label study in male and non-menstruating female subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Subjects will receive SPI-62 daily for up to 14 days. Subjects will also receive cortisone-d8, a mass-labeled HSD-1 substrate, by infusion during one or two confined study visits during the period of SPI-62 administration. Subjects may also receive cortisone-d8 during one to four additional confined study visits after cessation of SPI-62. Subjects will receive a follow-up call approximately 30 days after the last dose of study drug (SPI-62 or cortisone-d8). Results of population pharmacokinetic-pharmacodynamic modeling of data from this trial combined with those of prior trials will be reported separately from the Clinical Study Report.

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62
Actual Study Start Date : 2021-07-23
Estimated Primary Completion Date : 2022-03-10
Estimated Study Completion Date : 2024-02-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62

Location Details

NCT05409027

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How to Participate

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Locations

Not yet recruiting

United States, California

Proscient

Chula Vista, California, United States, 91911