Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565611
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-05
Brief Title:
A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Randomized Double-Blind Placebo-Controlled Clinical Study Investigating the Safety Tolerability and Effectiveness of the Co-Administration of Bremelanotide With Tirzepatide GLP-1GIP for the Treatment of Obesity
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BMT-801
Brief Summary:
This is a prospective randomized double-blind placebo-controlled study designed to assess the safety and efficacy of bremelanotide BMT used in combination with tirzepatide therapy in the treatment of obesity in subjects with a BMI ranging from 300 to 450 kgm2 inclusive
Detailed Description:
A total of approximately 60 subjects at approximately five to eight 5-8 centers within the United States US will be enrolled into the study for 8 weeks of treatment Subjects who provide written informed consent and meet all initial eligibility criteria will enter into Screening The subjects historical and current medical data will be collected reviewed and recorded to be used as baseline values
Enrolled subjects will begin the study and go through 2 treatment periods
Treatment Period 1 - 4 weeks of Tirzepatide therapy only
Treatment Period 2 - 4 weeks of combination therapy of bremelanotide Placebo or Tirzepatide therapy
Enrolled subjects will begin the study and go through 2 treatment periods
Treatment Period 1 - 4 weeks of Tirzepatide therapy only
Treatment Period 2 - 4 weeks of combination therapy of bremelanotide Placebo or Tirzepatide therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None