Trial · Interventional
Active, not recruitingPhase 4Registry dataBariatric Surgery vs. Semaglutide vs. Tirzepatide
Overview
- Status
- Active, not recruiting
- Phase
- Phase 4
- Enrollment
- 140 participants (estimated)
- Sponsor
- Ali Aminian · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 29 Jan 2025
- Primary completion
- 1 Jul 2027 (estimated)
- Completion
- 1 Dec 2027 (estimated)
- First posted
- 31 Jan 2025
- Last update posted
- 3 Sept 2026
- Conditions
- Obesity and Obesity-related Medical Conditions
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Bariatric SurgeryProcedure
- SemaglutideDrug
- TirzepatideDrug
Arms3
Active comparator
Bariatric Surgery
Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)
Active comparator
Semaglutide
Semaglutide, which is an incretin-based medication that has been approved for the treatment of obesity, will be used for this arm.
Active comparator
Tirzepatide
Tirzepatide, which is an incretin-based medication that has been approved for the treatment of obesity, will be used for this arm.
Primary outcomes1
Outcomes the sponsor listed as primary.
Mean percentage total body weight loss at Week 52
Time frame · Baseline to Week 52 after treatment initiation
Registry description
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
Secondary outcomes(18)
Percentage of Participants Achieving Weight Loss Milestones (Body weight related end points)
Time frame · Baseline to Week 52
Registry description
Percentage of participants achieving ≥5%, ≥10%, ≥15%, ≥20%, ≥25%, ≥30%, and ≥35% weight loss from baseline
Absolute Change in Weight (Body weight related end points)
Time frame · Baseline to Week 52
Registry description
Mean absolute change in weight measured in kilograms from baseline to 52 weeks
Absolute Change in BMI (Body weight related end points)
Time frame · Baseline to Week 52
Registry description
Absolute change in BMI measured in kg/m\^2 from baseline to 52 weeks
Excess Weight Loss Percentage (Body weight related end points)
Time frame · Baseline to Week 52
Registry description
Percentage of excess weight loss, calculated by dividing the difference between initial BMI and final BMI by the difference between initial BMI and a target BMI of 25
Change in Waist Circumference (Body weight related end points)
Time frame · Baseline to Week 52
Registry description
Change in waist circumferential measurement above the level of the iliac crests measured in centimeters from baseline to 52 weeks
Change in waist-to-height ratio (WHtR)
Time frame · Baseline to Week 52
Registry description
Change in waist-to-height ratio from baseline to Week 52
Systolic blood pressure trends
Time frame · Baseline to Week 52
Registry description
Mean and change in systolic blood pressure measured in mmHg
Mean and change from baseline in lipid panel
Time frame · Baseline to Week 52
Registry description
Mean and change from baseline in total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides measured in mg/dL
Changes in glucose homeostasis markers in T2DM patients
Time frame · Baseline to Week 52
Registry description
Mean and change from baseline in blood glucose (measured in mg/dL) and HbA1c (as a percentage) in patients with T2DM
Percentage of patients with T2DM meeting predefined HbA1c targets
Time frame · Baseline to Week 52
Registry description
Percentage of patients meeting different HbA1c targets, for example: * HbA1c \<6.5% (without diabetes medications) * HbA1c \<7% (irrespective of taking diabetes medications or not)
Changes in inflammatory marker, CRP
Time frame · Baseline to Week 52
Registry description
Mean and change from baseline in C-Reactive Protein (CRP) measured in mg/L
Changes in Lipoprotein(a)
Time frame · Baseline to Week 52
Registry description
Mean and change from baseline in Lipoprotein(a) measured in mg/dL
Change in cardiovascular and diabetes medications
Time frame · Baseline to Week 52
Registry description
Change in the number of cardiovascular and diabetes medications prescribed
Change from baseline in quality of life metrics
Time frame · Baseline to Weeks 52 and 104
Registry description
Change from baseline in score of The 36-Item Short Form Health Survey (SF-36) (physical and mental components). Each item is given a score ranging from 0-100. Lower scores indicating poor outcomes. Final score is an average of all the items that were answered. Unanswered questions are not included in the final average. Research coordinator completes the survey with the patient.
Change in body composition (via Seca mBCA 554 Bioimpedance Analysis)
Time frame · Baseline to Weeks 52
Registry description
Change in body composition (% fat mass and % fat-free mass) as measured by Seca mBCA 554 Bioimpedance Analysis to assess whether that weight loss is primarily caused by reduction in fat mass or not.
Mean change in liver fat content (via MRI-PDFF)
Time frame · Baseline to Weeks 52
Registry description
Mean change from baseline in liver fat content as assessed by MRI-PDFF measured as a percentage
Percentage of Participants Achieving ≥5%, ≥30%, ≥50% Absolute Reduction in Liver Fat Content (via MRI-PDFF)
Time frame · Baseline to Weeks 52
Registry description
Percentage of participants achieving at least 5%, 30%, or 50% relative reduction in liver fat content from baseline
Percentage of Participants Achieving MRI-PDFF Normalization (via MRI-PDFF)
Time frame · Baseline to Weeks 52
Registry description
Percentage of participants achieving MRI-PDFF normalization, defined as a liver fat content of \<5%, at week 52
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.