Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06282458
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-20
Brief Title:
Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt
Sponsor:
Veru Inc
Organization:
Veru Inc
Study Overview
Official Title:
A Phase 2 Dose-Finding and Proof-of-Concept Study to Evaluate the Effect on Body Composition and Safety of Enobosarm in Patients Treated With Glucagon-Like Peptide-1 GLP-1 Receptor Agonists for Chronic Weight Management
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:
QUALITY
Brief Summary:
The primary objective of this study is to assess the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists
Detailed Description:
This study is a multicenter randomized double-blind placebo-controlled dose-assessing study Subjects will be randomized to the three treatment arms GLP-1 receptor agonist plus either enobosarm 3mg dose group enobosarm 6mg dose group or placebo group in a 111 fashion All patients randomized into this study will be medically indicated for use of GLP-1 receptor agonist for weight management NOTE First dose of GLP-1 receptor agonist will be Day 1 of this study
The primary efficacy endpoint of the study will be the change from baseline in total lean mass at 4 months 112 days Subjects will continue enobosarm or matching placebo monotherapy treatment from Day 112 to Day 196 to assess the effect of enobosarm on total lean mass total muscle mass maintenance of weight loss and rebound fat gain after discontinuation of GLP-1 receptor agonists A safety follow up visit will occur approximately 30 days after last dose of study drug
The safety of enobosarm compared to the placebo control will be evaluated by an Independent Data Monitoring Committee IDMC
The primary efficacy endpoint of the study will be the change from baseline in total lean mass at 4 months 112 days Subjects will continue enobosarm or matching placebo monotherapy treatment from Day 112 to Day 196 to assess the effect of enobosarm on total lean mass total muscle mass maintenance of weight loss and rebound fat gain after discontinuation of GLP-1 receptor agonists A safety follow up visit will occur approximately 30 days after last dose of study drug
The safety of enobosarm compared to the placebo control will be evaluated by an Independent Data Monitoring Committee IDMC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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