Clofutriben for Type 2 Diabetes

(CAPTAIN-T2D Trial)

Recruiting at 41 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sparrow Pharmaceuticals

Must be taking: Injectable or oral ADMs

Must not be taking: Investigational drugs

Disqualifiers: Type 1 diabetes, Sleep apnea, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, clofutriben, for individuals with type 2 diabetes and high cortisol levels. Researchers aim to determine if clofutriben can manage blood sugar and cortisol levels more effectively than a placebo. Eligible participants should have a history of type 2 diabetes, be on stable diabetes medications, and have high blood sugar levels (HbA1c). Those who frequently experience complications like heart disease or high blood pressure and manage them with medication may be suitable candidates. As a Phase 2 trial, this research measures clofutriben's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires participants to maintain their current glucose-lowering medications, but they must be willing to adjust, add, replace, or discontinue these medications as directed by the investigator during the trial.

Is there any evidence suggesting that clofutriben is likely to be safe for humans?

Research shows that clofutriben, a treatment under study for type 2 diabetes, appears safe. Earlier studies found that clofutriben lowers certain enzyme activities in the body without causing serious side effects. Most participants tolerated clofutriben well, experiencing few unwanted effects. Some reports also indicate that clofutriben helps control blood sugar levels safely.

While these findings are promising, they come from smaller studies. Larger studies are needed to confirm the treatment's safety and effectiveness. For those considering joining a trial, these early results suggest clofutriben could be a safe option, but staying informed and asking questions is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about clofutriben for type 2 diabetes because it offers a potentially new approach to managing the condition. Unlike standard treatments such as metformin, sulfonylureas, or insulin, which primarily focus on improving insulin sensitivity or increasing insulin secretion, clofutriben's unique mechanism targets different pathways to regulate blood sugar levels more effectively. Additionally, clofutriben is being tested in varying doses, from 0.2 mg to 12 mg, to find the optimal balance of efficacy and minimal side effects. This flexibility in dosing could offer personalized treatment options for patients.

What evidence suggests that clofutriben might be an effective treatment for type 2 diabetes?

Research has shown that clofutriben may help manage type 2 diabetes by improving blood sugar control. It blocks an enzyme involved in cortisol production, a hormone that can worsen diabetes when present in excess. By reducing cortisol, clofutriben might alleviate diabetes symptoms. Trials indicate that most participants tolerated clofutriben well, experiencing no serious side effects. Early results suggest it could positively affect blood sugar levels in individuals with type 2 diabetes and obesity, making it a promising option for these conditions. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

The CAPTAIN-T2D trial is for individuals with type 2 diabetes who may also have high cortisol levels, suggesting a risk of ACTH or Cushing's Syndrome. Participants must pass a screening showing elevated cortisol to join the treatment phase where they'll be randomly assigned to receive either clofutriben or a placebo.

Inclusion Criteria

I will talk to the medical monitor about my insulin pump or if I change my insulin brand.

HbA1c ≥7.5% at Screening 2

I haven't changed or started any new blood pressure medicines in the last month.

Exclusion Criteria

I do not have severe health issues like uncontrolled blood pressure, drug use, kidney problems, thyroid disorders, liver issues, or allergies to certain medications.

I was diagnosed with diabetes less than a year ago.

Unwillingness to comply with CGM or other trial procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5-9 weeks

Multiple visits for eligibility assessments and dexamethasone suppression test

Treatment

Participants are randomized to receive either clofutriben or placebo for 24 weeks

24 weeks

Regular visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 follow-up phone call

What Are the Treatments Tested in This Trial?

Interventions

• Clofutriben

Trial Overview

This study tests clofutriben against a placebo in people with type 2 diabetes and potential cortisol issues. It's double-blind, meaning neither participants nor researchers know who gets the real drug versus the placebo during the dose-ranging treatment part of the trial.

How Is the Trial Designed?

Group I: Dose 4 Experimental Treatment 1 Intervention

clofutriben 12 mg oral tablet daily

Group II: Dose 3 Experimental Treatment 1 Intervention

clofutriben 6mg oral tablet daily

Group III: Dose 2 Experimental Treatment 1 Intervention

clofutriben 2mg oral tablet daily

Group IV: Dose 1 Experimental Treatment 1 Intervention

clofutriben .2 mg oral tablet daily

Group V: placebo Placebo Group 1 Intervention

placebo control oral tablet daily

Who Is Running the Clinical Trial?

Sparrow Pharmaceuticals

Lead Sponsor

Trials

5

Recruited

160+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07296484?cond=cancer

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

The primary objectives of this trial are to characterize the relationship of clofutriben dose to improved glycemic control, and to identify one ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12619576/

Human Adipose Tissue 11β‐Hydroxysteroid Dehydrogenase ...

We report measurement of adipose HSD‐1 inhibition by clofutriben in persons with type 2 diabetes and obesity, who have elevated adipose HSD‐1 ...

3.

rivervest.com

rivervest.com/2025/09/24/could-excess-cortisol-be-driving-type-2-diabetes-resistance/

Could Excess Cortisol Be Driving Type 2 Diabetes ...

Clofutriben has been associated with improved glycemic control while generally safe and well tolerated in multiple clinical trials without ...

4.

ard.eular.org

ard.eular.org/article/S0003-4967%2825%2904454-1/fulltext

Effects of clofutriben, a selective 11β-hydroxysteroid ...

Glucocorticoids effectively treat many diseases, but toxicity limits their utility. We aimed to learn whether, by reducing active ...

5.

linkedin.com

linkedin.com/posts/sparrowpharma_type2diabetes-cortisol-activity-7384589051040956416-KaTN

Phase 2b trial for clofutriben in type 2 diabetes

Alirocumab, a PCSK9 inhibitor, has emerged as an effective alternative in such cases, but real-world data from the Middle East remains limited.

6.

endocrine-abstracts.org

endocrine-abstracts.org/ea/0110/ea0110rc4.3

Clofutriben inhibits 11ß-hydroxysteroid dehydrogenase ...

Conclusions: Clofutriben decreased hepatic HSD-1 activity adequately to confer clinical benefit while maintaining safety and overall tolerability. These limited ...

7.

academic.oup.com

academic.oup.com/jes/article/doi/10.1210/jendso/bvaf149.1471/8298846

OR12-04 Clofutriben, an 11beta-Hydroxysteroid ...

... safety and overall tolerability. These limited data support clofutriben's potential for clinical improvement without adrenal insufficiency.