Type 2 Diabetes Mellitus in ObesePhase 1NCT05409027
A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62
A Phase 1 study testing SPI-62 and Cortisone-d8 in people with Type 2 Diabetes Mellitus in Obese and Obesity, run by Sparrow Pharmaceuticals at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus in Obese, Obesity, Type2Diabetes
- What is being tested?
- SPI-62 and Cortisone-d8
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2021to 7 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus in Obese, Obesity, Type2Diabetes
- Being tested
- SPI-62, Cortisone-d8
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI-62Drug
Also called HSD-1 inhibitor
SPI-62 is supplied as 1 mg tablets for oral dosing.
Cortisone-d8Drug
Also called Glucocorticoid and anti-inflammatory agent
Cortisone-d8 is supplied as a 1 mcg/mL solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SPI-62; Drug: Cortisone-d8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (Cmax)
Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Observed Maximum Plasma Concentration (Cmax)
Measured: Days 1 through 14
Secondary outcomes (4)
Pharmacokinetics (tmax)
Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Time to Cmax (tmax)
Measured: Days 1 through 14
Pharmacokinetics (AUC0-t)
Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Area Under the Curve over the dosing interval
Measured: Days 1 through 14
Cortisone-d8 concentrations
individual values
Measured: Days 1 through 14
Urinary HSD-1 Ratio
Individual values of the urinary HSD-1 ratio defined as (tetrahydrocortisol + allotetrahydrocortisol) / tetrahydrocortisone
Measured: Days -1 to 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start23 Jul 2021
- Primary completion10 Mar 2022
- Study completion7 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus in ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sparrow Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Katz, PhD, Study director, Sparrow Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409027
- Sponsor's protocol ID
- SPI-62-CL-1001
- Status last verified
- Apr 2024
- First submitted
- 23 Mar 2022
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
An G, Gutierrez JA, Abad-Zapatero C, Lin SK, Schmicker C, Rinas A, Engel B, Magers T, Marmon TK, Katz DA. Human Adipose Tissue 11beta-Hydroxysteroid Dehydrogenase Type 1 Inhibition Without Tachyphylaxis by Clofutriben, a Pseudo-Irreversible Enzyme Inhibitor. Clin Transl Sci. 2025 Nov;18(11):e70398. doi: 10.1111/cts.70398.
PubMed 41240060
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62
- ClinicalTrials.gov ID
- NCT05409027
- Acronym / sponsor ID
- SPI-62-CL-1001
- Conditions
- Type 2 Diabetes Mellitus in Obese, Obesity, Type2Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sparrow PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: SPI-62, Drug: Cortisone-d8Each 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPI-62Also: HSD-1 inhibitorSPI-62 is supplied as 1 mg tablets for oral dosing. | Drug | Single Arm |
| Cortisone-d8Also: Glucocorticoid and anti-inflammatory agentCortisone-d8 is supplied as a 1 mcg/mL solution for infusion | Drug | Single Arm |
Primary outcome
Pharmacokinetics (Cmax)
Time frame: Days 1 through 14
Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Observed Maximum Plasma Concentration (Cmax)
4 secondary outcomes
Pharmacokinetics (tmax)
Time frame: Days 1 through 14
Pharmacokinetics (AUC0-t)
Time frame: Days 1 through 14
Cortisone-d8 concentrations
Time frame: Days 1 through 14
Urinary HSD-1 Ratio
Time frame: Days -1 to 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Derived from this study: PubMed 41240060An G, Gutierrez JA, Abad-Zapatero C, Lin SK, Schmicker C, Rinas A, Engel B, Magers T, Marmon TK, Katz DA. Human Adipose Tissue 11beta-Hydroxysteroid Dehydrogenase Type 1 Inhibition Without Tachyphylaxis by Clofutriben, a Pseudo-Irreversible Enzyme Inhibitor. Clin Transl Sci. 2025 Nov;18(11):e70398. doi: 10.1111/cts.70398.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Katz, PhD study director
Sparrow Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPI-62 and Cortisone-d8 in people with Type 2 Diabetes Mellitus in Obese and Obesity, run by Sparrow Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (Cmax) (time frame: Days 1 through 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05409027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.