Trial · Interventional
Not yet recruitingPhase 4Registry dataTapered Versus Abrupt Discontinuation of Semaglutide After Treatment of Recurrent Weight Gain or Suboptimal Response Following Metabolic and Bariatric Surgery
Overview
- Status
- Not yet recruiting
- Phase
- Phase 4
- Enrollment
- 100 participants (estimated)
- Sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt · Other gov
- Design
- Randomized · Quadruple masking
- Countries
1 country
Egypt
- Start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Completion
- Apr 2028 (estimated)
- First posted
- 5 Oct 2026
- Last update posted
- 5 Oct 2026
- Conditions
- Morbid Obesity
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Tapered Versus Abrupt Discontinuation of Semaglutide After Treatment of Recurrent Weight Gain or Suboptimal Response Following Metabolic and Bariatric Surgery
NCT07859176est. Oct 2026 to est. Apr 2028
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Every course of obesity pharmacotherapy ends. Cost, supply, pregnancy plans, side effects, or the patient's own wish. In Egypt, cost alone makes discontinuation the rule, not the exception. Yet the entire evidence base describes what happens when the drug stops, and none of it tests how to stop. Abrupt withdrawal fails predictably. One year after stopping semaglutide, STEP 1 extension participants had regained two thirds of their lost weight. SURMOUNT-4 showed the same pattern after tirzepatide withdrawal, and meta-analysis confirms it across agents. After MBS specifically, stopping GLP-1 therapy is likewise followed by regain. The guidelines say: do not stop at all. The 2026 ADA and Obesity Association Standards strongly recommend continuing medication through maintenance, and the 2024 IFSO consensus agrees that when medication is needed to hold the benefit after MBS, ongoing treatment is probably necessary, while stating, at 94% agreement, that intermittent therapy and dose-reduction strategies require research. Our patients cannot follow the first recommendation. Cost decides for them. This trial is the research the second sentence asks for: the evidence for the moment when continuing is not an option. Clinicians already taper, on no evidence. A 2025 expert commentary describes 8-to-12-week dose reductions in routine practice and states plainly that the approach is anecdotal and untested (Obesity and Endocrinology 2025). Practice has run ahead of the trial. The general-population trial now exists, and we cite it rather than duplicate it. The REST trial has registered exactly this comparison, gradual 16-week dose reduction versus abrupt cessation, in non-surgical patients with obesity. No such trial exists after MBS.
Interventions
- Semaglutide weekly injectionDrug
- PlaceboDrug
Arms2
Active comparator
Taper
active pens at 1.7 mg for 4 weeks, then 1.0, 0.5, and 0.25 mg for 4 weeks each; injections stop at week 16.
Placebo comparator
Abrupt
matched placebo pens on the identical schedule from week 0; injections stop at week 16.
Primary outcomes1
Outcomes the sponsor listed as primary.
Percentage change in body weight
Time frame · Baseline till 18 months
Registry description
Measured in kilograms from randomization to month 12, measured on the same calibrated scale, morning, light clothing.
Secondary outcomes(9)
Weight change
Time frame · 6, 18 months
Registry description
measured in kilograms
Proportion weight
Time frame · baseline till 18 months
Registry description
regaining more than 25% and more than 50% of the weight lost during treatment.
Recurrent weight gain
Time frame · Baseline till 18 months
Registry description
Recurrent weight gain (RWG) is defined by the July 2026 international Delphi consensus as gaining more than 25% of the weight that was initially lost from the post-surgical nadir (the lowest weight point achieved after metabolic and bariatric surgery) Panel and Scope: A two-round modified Delphi study published in mid-2026 involved 66 international experts across five medical specialties to standardize definitions following metabolic and bariatric surgery (MBS) Preferred Terminology: The panel established "suboptimal" as the preferred overarching term (89.5% consensus) Optimal Measurement Metric: Percentage of Total Weight Loss (%TWL) was voted the optimal measurement approach (94.6% consensus) Related Thresholds: * Surgical nonresponse: Less than 10% TWL at 12 months (73.0% consensus). * Normal physiologic response: A 10% fluctuation in percentage of excess weight loss (%EWL) from the nadir (83.8% consensus).
Time to pharmacotherapy restart
Time frame · Baseline till 18 months
Registry description
Restart rule: after month 6, open-label pharmacotherapy may be restarted only if the Delphi recurrence criteria are met; every restart is recorded and the patient stays in follow-up. The primary analysis is treatment-policy; a hypothetical estimand ignoring restart is a supporting analysis.
Hand-grip strength
Time frame · 0, 6, 12 months
Registry description
A hand grip strength test measures the maximum force of your hand and forearm muscles using a portable device called a handgrip dynamometer. Position yourself: Sit up straight with your feet flat on the floor. Place your arm by your side with your elbow bent at a 90-degree angle and your wrist in a neutral position. Hold the device: Adjust the handle so it fits comfortably in your hand. Squeeze hard: Squeeze the handles as hard as you can for about 3 to 5 seconds without moving your arm or resting the device against your body. Repeat trials: Take three measurements for each hand, resting for 15 to 30 seconds between attempts. Use either the highest score or the average of the trials. A normal hand grip strength score typically ranges from 40 to 56 kg (88 to 123 lbs) for adult men and 25 to 36 kg (55 to 79 lbs) for adult women aged 20-29.
waist circumference
Time frame · 0, 6, 12 months
Registry description
Waist circumference is a direct measurement of belly fat that helps assess your risk for chronic health issues like heart disease and type 2 diabetes. Health risk increases when waist size goes past certain thresholds: Men: High risk starts above 102 cm (40 inches) according to standard guidelines, though some organizations flag risks starting at 94 cm (37 inches). Women: High risk starts above 88 cm (35 inches), with tighter thresholds starting at 80 cm (31.5 inches) in some regional guidelines.
change in HbA1c
Time frame · 0, 6, 12 months
Registry description
An HbA1c level reflects your average blood sugar over the past two to three months, and any meaningful change typically takes at least 6 weeks to show because red blood cells live for about 3 months. Normal: Below 5.7% Prediabetes: 5.7% to 6.4% Diabetes: 6.5% or higher
total cholesterol, LDL, HDL, and triglycerides
Time frame · 0, 6, 12 months
Registry description
Normal adult values for a lipid panel are measured in milligrams per deciliter (mg/dL): • Total Cholesterol: Below 200 mg/dL is desirable. (Borderline high is 200-239 mg/dL, and high is 240 mg/dL and above.) • LDL ("Bad") Cholesterol: Below 100 mg/dL is optimal. (130-159 mg/dL is borderline high, and 160-189 mg/dL or higher is high.) • HDL ("Good") Cholesterol: 60 mg/dL and higher is protective. Levels below 40 mg/dL for men or below 50 mg/dL for women are considered low. • Triglycerides: Below 150 mg/dL is normal. (Borderline high is 150-199 mg/dL, and high is 200-499 mg/dL.)
De novo restrictive eating behavior
Time frame · 0, 6, 12, 18 months
Registry description
Is an adverse event of special interest, after the single suspected unexpected serious adverse reaction in BARI-STEP; investigators screen for it at every visit, with an urgent psychology referral pathway.
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 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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