Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2025-12-17 @ 12:57 AM
Study NCT ID:
NCT06445075
Status:
None
Last Update Posted:
2025-07-17 00:00:00
First Post:
2024-05-22 00:00:00
Brief Title:
Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese
Sponsor:
Scholar Rock Inc
Organization:
Scholar Rock, Inc.
Study Overview
Official Title:
A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apitegromab in Overweight and Obese Adult Subjects
Status:
None
Status Verified Date:
2025-07
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:
EMBRAZE
Brief Summary:
This phase 2 randomized, double-blind, placebo-controlled, multicenter study assessed the safety, efficacy, and pharmacokinetics (PK) of apitegromab when used as an adjunctive therapy to GLP-1 receptor agonist therapy in subjects with overweight and obesity and without diabetes. Each subject received tirzepatide throughout the treatment period. In addition, all subjects were randomized 1:1 to receive either apitegromab or placebo during the treatment period.
Detailed Description:
This phase 2 randomized double-blind placebo-controlled multicenter study will assess the safety efficacy and pharmacokinetics PK of apitegromab when used as an adjunctive therapy to GLP-1 agonist therapy in subjects with overweight and obesity and without diabetes Each subject will receive either semaglutide or tirzepatide depending upon availability and will maintain that course throughout the treatment period In addition all subjects will be randomized 11 to receive either apitegromab or placebo during the treatment period
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