NCT05409027CompletedPhase 1
A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62
Source: ClinicalTrials.gov · Last updated 22 Apr 2024
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 23 Mar 2022
- Start date
- 23 Jul 2021
- Primary completion date
- 10 Mar 2022
- Lead sponsor
- Sparrow Pharmaceuticals
- Diseases
- Obesity, Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05409027
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- From 23 Jul 2021 to the primary completion date, 10 Mar 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results.
- 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.
Lab values
- Uncontrolled T2DM with glycated hemoglobin ≥9.5%.
- Any clinically significant abnormal laboratory value which cannot be explained by a known and permitted clinical condition.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ProSciento Coordinator of this site? Confirm its status | Chula Vista | United States | Unknown status |
Related publications
- Human Adipose Tissue 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibition Without Tachyphylaxis by Clofutriben, a Pseudo-Irreversible Enzyme Inhibitor.Clin Transl Sci · 2025 · PMID 41240060
This page is information, not medical advice. Discuss any trial with your doctor.