Join Trial Researching New Medication for Diabetic Kidney Disease
By April Hopcroft
This trial is investigating a new oral medication, INV-202, which is designed to improve regulation in the kidney, liver, and pancreas.
Clinical Trials Identifier: NCT05514548
Trial Name: Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease
Diabetes Type: Adults with kidney disease due to either type 1 or type 2 diabetes
Trial Sponsor: Inversago Pharma Inc.
What is the trial researching?
The study will investigate the safety and efficacy of an investigational medicine, INV-202, in people who have been diagnosed with kidney disease that’s a result of type 1 or type 2 diabetes.
Researchers will measure the change in urinary albumin creatinine ratio (UACR, a measure of kidney damage) and estimated glomerular filtration rate (eGFR, a measure of kidney function) during the study period.
INV-202 is a peripherally-acting cannabinoid receptor (CB1) inverse agonist that blocks receptors involved in regulating metabolism and appetite. The drug is being developed to treat a range of metabolic conditions, including diabetes, obesity, kidney disease, and fatty liver disease. In an early trial, INV-202 led to an average weight loss of nearly 8 pounds, compared with a weight gain of roughly one pound for participants taking a placebo.
Previously, pharmaceutical companies had studied similar drugs for obesity (for example, Rimonabant), but they had unacceptable psychiatric side effects including suicidality. INV-202 was designed to only act peripherally and not cause psychiatric side effects.
The study plans to enroll 240 people who will receive INV-202 or a placebo for 16 weeks. The full study will last approximately 22 weeks.
Why is this important?
About 20-40% of people with diabetes develop chronic kidney disease (CKD). CKD is a progressive disease, meaning that it worsens over time and can eventually result in the need for dialysis or a kidney transplant. People with diabetes and CKD are not only at risk for worsening kidney disease and kidney failure but also have a higher chance of cardiovascular disease.
SGLT-2 inhibitors have been shown to reduce the risk of worsening CKD and kidney failure. Most recently, Jardiance (empagliflozin) was approved in the U.S. and Europe for people with CKD, regardless of diabetes status.
While there are several treatments approved for people with type 2 diabetes and CKD – such as SGLT-2 inhibitors and Kerendia (finerenone) – there are few options currently approved for people with type 1 diabetes and CKD. However, Kerendia and GLP-1 receptor agonists are being studied for type 1 diabetes.
If INV-202 is successful, it could advance to large-scale phase 3 trials and gain FDA approval for people with type 1 and type 2 diabetes. An approval in type 1 diabetes would be especially exciting, given the lack of approved treatment options beyond the ACE inhibitor captopril (sold under the brand name Capoten).
Are you interested?
You may be eligible if you:
-
Are at least 18 years old.
-
Have been diagnosed with kidney disease due to either type 1 or type 2 diabetes (diagnosed for at least 1 year).
-
Are on stable diabetes treatment and have an A1C <9.5%.
-
Participants with type 1 diabetes may not be on any glucose lowering medications beyond insulin.
-
Participants with type 2 diabetes may be on more than 1 diabetes medication (eg, SGLT-2 inhibitors, insulin, or other diabetes medications).
-
Have been on a stable dose of ACE inhibitor or ARB for at least 4 months prior to the study and expected to remain stable for the 4-month treatment period.
-
Have albuminuria with a UACR >100 mg/g and <3000 mg/g.
See a full list of inclusion/exclusion criteria here. This study is currently recruiting in many locations across the US, Canada, Georgia, Hungary, Israel, Mexico, and Serbia.
For more information: To learn more about this study, contact the study team at clinicalstrials-inquiries@inversago.com or call (+1) 919-371-8411.
Learn more about kidney disease and diabetes here:
