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NCT06803888 · ClinicalTrials.gov registry record · Phase 4
Bariatric Surgery vs. Semaglutide vs. Tirzepatide
A Phase 4 study of Obesity and Obesity-related Medical Conditions, sponsored by Ali Aminian.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 125
- Enrollment target
- 1
- Study location
NCT06803888: Recruiting Phase 4 study of Obesity and Obesity-related Medical Conditions, sponsored by Ali Aminian.
NCT06803888 is a Phase 4 study of Obesity and Obesity-related Medical Conditions that is actively recruiting participants, run by Ali Aminian. The registered enrollment target is 125 participants, below the 528-participant average among 13 other Obesity and Obesity-related Medical Conditions trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06803888, a Phase 4 study of Obesity and Obesity-related Medical Conditions, is actively recruiting participants, sponsored by Ali Aminian.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 125 participants
- Enrollment target
- 1
- Study location
Study Summary
The recent introduction of the new generation of anti-obesity medications (AOMs) will change the future of obesity treatment. These highly effective medications, such as high-dose semaglutide and tirzepatide, are hormone analogues that augment the incretin function and exert multiple physiological effects by activating glucagon-like peptide-1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) distributed in various organs. These medications provide an average of 15-22% weight reduction in one-year trials, which had not been seen in the past with medical therapy. While the literature suggests that bariatric surgery is superior to these new highly effective medications, there is no head-to-head comparison between the most common bariatric operations (Roux-en-Y gastric bypass \[RYGB\] and sleeve gastrectomy \[SG\]) with semaglutide (once weekly) and tirzepatide (once weekly). The goal of this Randomized Clinical Trial (RCT) is to compare these effective therapies in patients with severe obesity to provide the best evidence to inform clinical decisions in treating patients with obesity.
Primary Outcome
The mean percentage weight loss at 52 weeks after treatment initiation for the following 2 comparisons: * Bariatric surgery (RYGB and SG) vs tirzepatide * Bariatric surgery (RYGB and SG) vs semaglutide
Conditions Studied
Interventions
- DRUG Tirzepatide
- DRUG Semaglutide
- PROCEDURE Bariatric Surgery
Study Locations (1)
Ohio
- The Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2025-01-29 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 4 |
What NCT06803888 shows while recruiting
NCT06803888 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 528-participant average among 13 other Obesity and Obesity-related Medical Conditions trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Obesity and Obesity-related Medical Conditions appearing as the primary indexed condition, and to 3 interventions - of which Tirzepatide is the first listed.
NCT06803888 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06803888 about?
NCT06803888 is a clinical study titled "Bariatric Surgery vs. Semaglutide vs. Tirzepatide". The recent introduction of the new generation of anti-obesity medications (AOMs) will change the future of obesity treatment. These highly effective medications, such as high-dose semaglutide and tirzepatide, are hormone analogues that augment the incretin function and exert multiple physiological e...
What is the current status of trial NCT06803888?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 125 participants. The study started on 2025-01-29. Estimated completion is 2027-12-01.
What conditions does trial NCT06803888 study?
This clinical trial studies the following conditions: Obesity and Obesity-related Medical Conditions.
What interventions are being tested in trial NCT06803888?
The interventions under investigation include: Tirzepatide (DRUG), Semaglutide (DRUG), Bariatric Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT06803888?
This trial is sponsored by Ali Aminian, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06803888 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06803888's enrollment target sits among peer trials
125 3rd of 13 higher than 11 of 13 other Obesity and Obesity-related Medical Conditions trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity and Obesity-related Medical Conditions trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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