NCT05409027 is a Phase 1 clinical trial of SPI-62 in Type 2 Diabetes Mellitus in Obese, sponsored by Sparrow Pharmaceuticals.

Who is sponsoring NCT05409027?

NCT05409027 is sponsored by Sparrow Pharmaceuticals.

What drugs are being tested in NCT05409027?

Interventions in NCT05409027: SPI-62, Cortisone-d8.

What condition does NCT05409027 study?

NCT05409027 studies Type 2 Diabetes Mellitus in Obese, Obesity, Type2Diabetes.

Is NCT05409027 still recruiting?

NCT05409027 is currently completed. Last updated 22 April 2024.

Last reviewed 2024-04-22 · How we verify

NCT05409027

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 22 April 2024

What this trial tests

Phase 1 trial testing SPI-62 in Type 2 Diabetes Mellitus in Obese in 12 participants. Completed in 7 February 2024.

Timeline

23 July 2021

Primary endpoint
10 March 2022

7 February 2024

Quick facts

Lead sponsor	Sparrow Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	12
Start date	23 July 2021
Primary completion	10 March 2022
Estimated completion	7 February 2024
Sites	1 location across United States

Drugs / interventions tested

SPI-62 — full drug profile →
Cortisone-d8 — full drug profile →

Conditions studied

Type 2 Diabetes Mellitus in Obese — all drugs for Type 2 Diabetes Mellitus in Obese →
Obesity — all drugs for Obesity →
Type2Diabetes — all drugs for Type2Diabetes →

Sponsor

Sparrow Pharmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Type 2 Diabetes Mellitus in Obese or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Human Adipose Tissue 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibition Without Tachyphylaxis by Clofutriben, a Pseudo-Irreversible Enzyme Inhibitor.
An G, Gutierrez JA, Abad-Zapatero C, Lin SK, et al · · 2025 · cited 1× · PMID 41240060 · DOI 10.1111/cts.70398

Verify or expand the search:

Other trials of SPI-62

Trials testing the same drug.

NCT05307328 — SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome · Phase 2 · completed
NCT05436652 — A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR) · Phase 2 · completed
NCT06281236 — A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR) · Phase 1 · terminated

Other recruiting trials for Type 2 Diabetes Mellitus in Obese

Currently open trials in the same condition.

NCT06682481 — Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function · recruiting
NCT05277558 — Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D) · recruiting

Other Sparrow Pharmaceuticals trials

Trials by the same sponsor.

NCT07227922 — Clofutriben Pharmacokinetics in Patients With Impaired Renal Function · Phase 1 · recruiting
NCT07296484 — Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D) · Phase 2 · recruiting
NCT07226635 — Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone · Phase 1 · completed
NCT05436639 — SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor · Phase 2 · completed
NCT05307328 — SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05409027 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sparrow Pharmaceuticals
Last refreshed: 22 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05409027.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing