INV 202 10 mg for Diabetic Nephropathy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diabetic Nephropathy+2 More
INV-202 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug in the treatment of adult participants with a diagnosis of Diabetic Kidney Disease due to either Type 1 diabetes mellitus or Type 2 diabetes mellitus

Eligible Conditions
  • Diabetic Nephropathy

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 16 weeks

16 weeks
Change in UACR from baseline to W16
Change in eGFR using cystatin C and the CKD-EPI formula from baseline to W16
Body Weight Changes
Change in urine protein to creatinine ratio (UPCR) from baseline to W16

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

INV 202 10 mg
1 of 3
INV-202 25 mg
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

240 Total Participants · 3 Treatment Groups

Primary Treatment: INV 202 10 mg · Has Placebo Group · Phase 2

INV 202 10 mg
Drug
Experimental Group · 1 Intervention: INV-202 · Intervention Types: Drug
INV-202 25 mg
Drug
Experimental Group · 1 Intervention: INV-202 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INV-202
2022
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks

Who is running the clinical trial?

Worldwide Clinical TrialsOTHER
50 Previous Clinical Trials
11,694 Total Patients Enrolled
Inversago Pharma Inc.Lead Sponsor
2 Previous Clinical Trials
77 Total Patients Enrolled
Glenn Crater, MDStudy DirectorInversago Pharma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old.\n
You are able and willing to give informed consent and to comply with scheduled visits and trial procedures.
You have a diagnosis of DKD due to either T1DM or T2DM (diagnosed for ≥1 year).
HbA1c should have been performed within the last 4 months prior to randomization.
You have albuminuria with a UACR >100 mg/g and <3000 mg/g at screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: November 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.