Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT05891834
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 kg/m2) 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 and/or 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:
NCT05891834
Study Brief:
Protocol Section:
NCT05891834