Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05327127 |
|
Recruitment Status :
Recruiting
First Posted : April 14, 2022
Last Update Posted : December 5, 2022
|
Sponsor:
Kowa Research Institute, Inc.
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| NASH | Drug: K-877-ER Drug: CSG452 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 400 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Study to Evaluate the Efficacy and Safety of Combination Therapy of K-877-ER and CSG452 in Participants With Noncirrhotic Nonalcoholic Steatohepatitis (NASH) With Liver Fibrosis |
| Actual Study Start Date : | November 14, 2022 |
| Estimated Primary Completion Date : | April 2025 |
| Estimated Study Completion Date : | May 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
North American Indian childhood cirrhosis
| Arm | Intervention/treatment |
|---|---|
|
Experimental: K-001
K-877-ER and CSG452 Once daily (QD)
|
Drug: K-877-ER
K-877-ER tablet Drug: CSG452 CSG452 tablet |
|
Experimental: K-877-ER
K-877-ER and CSG452 Placebo QD
|
Drug: K-877-ER
K-877-ER tablet Drug: Placebo Placebo tablet |
|
Experimental: CSG452
CSG452 and K-877-ER Placebo QD
|
Drug: CSG452
CSG452 tablet Drug: Placebo Placebo tablet |
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo tablet |
Primary Outcome Measures :
- Improvement in disease activity and no worsening of liver fibrosis (Yes/No) [ Time Frame: Baseline to Week 48 ]The improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥2 points. The worsening of fibrosis is defined as any numerical increase in the stage.
Secondary Outcome Measures :
- Number of Participants With Treatment-Related Adverse Events (AE) [ Time Frame: 52 Weeks ]Time frame is 52 weeks unless an unresolved AE is still being followed
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Able to understand and comply with study procedures and give written informed consent
- Age ≥18 years
- NAS ≥4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 12 weeks of randomization
- Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network) fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsy performed within 12 weeks of randomization
- Meet all inclusion criteria outlined in clinical study protocol
Exclusion Criteria:
- Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study
- Ongoing or recent consumption of significant amounts of alcohol as defined in clinical study protocol
- Evidence of other forms of chronic liver disease as defined in clinical study protocol
- Does not meet any other exclusion criteria outlined in clinical study protocol
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05327127
Contacts
| Contact: Director, Clinical Operations | 919-433-1600 | Clinical@KowaUS.com |
Locations
Show 32 study locations
Sponsors and Collaborators
Kowa Research Institute, Inc.
Investigators
| Study Chair: | Shona Pendse, MD, MMSc | Kowa Research Institute, Inc. |
| Responsible Party: | Kowa Research Institute, Inc. |
| ClinicalTrials.gov Identifier: | NCT05327127 |
| Other Study ID Numbers: |
K-001-201 |
| First Posted: | April 14, 2022 Key Record Dates |
| Last Update Posted: | December 5, 2022 |
| Last Verified: | December 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Liver Cirrhosis Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases |
6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs |