Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05891834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-05-17
Brief Title:
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
Sponsor:
Inversago Pharma Inc
Organization:
Inversago Pharma Inc
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Study of the Efficacy Safety and Pharmacokinetics of 3 Doses of INV-202 With an Optional Open-Label Extension in Patients With Obesity and Metabolic Syndrome
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 obesity and metabolic syndrome
Detailed Description:
This will be a 2-part study Part A will be a randomized double-blind placebo-controlled dose ranging multicenter study assessing the efficacy safety tolerability and PK of INV-202 for the treatment of adult participants with obesity BMI 30 kgm2 and metabolic syndrome
An informed consent form ICF must be signed by the participant before any study-related procedures are performed
Each participant will be allowed 1 retest during the screening period if they have an abnormal test result not meeting eligibility criteria that is deemed transient by the investigator Participants who did not meet all eligibility criteria may be re-screened once with approval of the medical monitor
Participants will return to the study site at Weeks 4 8 12 and 16 At these visits the same assessment as baseline will be completed
During Part A a subset of approximately 20 to 30 participants from an estimated 3 to 4 study sites will have DEXA performed at baseline and Week 16 for exploratory assessments of change in total body fat percentage and skeletal muscle mass Additional exploratory measures will include lung function with oscillometry Any participant who withdraws from Part A before completing treatment will be requested to return for an early termination visit at which time the procedures normally scheduled for the Week 16 visit will be conducted
Participants completing Part A will be eligible to enroll to the open-label extension OLE Part B if they did not have significant noncompliance with study drug visits or procedures and did not meet any withdrawal criteria During Part B the efficacy and safety of INV-202 20 mg daily pending results of chronic toxicology studies andor findings from this and other ongoing clinical studies the alternative dose would be 10 mg will be further evaluated over an additional 36 weeks through Week 52
An informed consent form ICF must be signed by the participant before any study-related procedures are performed
Each participant will be allowed 1 retest during the screening period if they have an abnormal test result not meeting eligibility criteria that is deemed transient by the investigator Participants who did not meet all eligibility criteria may be re-screened once with approval of the medical monitor
Participants will return to the study site at Weeks 4 8 12 and 16 At these visits the same assessment as baseline will be completed
During Part A a subset of approximately 20 to 30 participants from an estimated 3 to 4 study sites will have DEXA performed at baseline and Week 16 for exploratory assessments of change in total body fat percentage and skeletal muscle mass Additional exploratory measures will include lung function with oscillometry Any participant who withdraws from Part A before completing treatment will be requested to return for an early termination visit at which time the procedures normally scheduled for the Week 16 visit will be conducted
Participants completing Part A will be eligible to enroll to the open-label extension OLE Part B if they did not have significant noncompliance with study drug visits or procedures and did not meet any withdrawal criteria During Part B the efficacy and safety of INV-202 20 mg daily pending results of chronic toxicology studies andor findings from this and other ongoing clinical studies the alternative dose would be 10 mg will be further evaluated over an additional 36 weeks through Week 52
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None