SPI-62 for Type 2 Diabetes in Obesity

Phase 1

Waitlist Available

Research Sponsored by Sparrow Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days -1 to 15

Awards & highlights

Study Summary

This trial will study if an inhibitor of HSD-1 can help improve diabetes in obese people with T2DM.

Who is the study for?

This trial is for obese adults aged 18-65 with type 2 diabetes. Participants should have a BMI between 30.0 to 45.0 kg/m2 and have been diagnosed with diabetes for at least three months. Non-menstruating females or males can join, but not if they've used certain meds or supplements recently, participated in other drug trials within the last month (or longer), failed drug/alcohol tests, or have uncontrolled diabetes.Check my eligibility

What is being tested?

The study is testing SPI-62's ability to inhibit an enzyme called HSD-1 in fat tissue of people with obesity and type 2 diabetes. It's an open-label study, meaning everyone knows what treatment they're getting—there are no placebos or blinding involved.See study design

What are the potential side effects?

Potential side effects aren't specified here, but generally speaking, drugs like SPI-62 could cause changes in blood sugar levels, possible hormonal imbalances due to enzyme inhibition, and typical drug-related reactions such as nausea or headaches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days -1 to 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days -1 to 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and days -1 to 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pharmacokinetics (Cmax)

Secondary outcome measures

Cortisone-d8 concentrations

Pharmacokinetics (AUC0-t)

Pharmacokinetics (tmax)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment2 Interventions

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.

Do I qualify?Apply below to find out