Morbid ObesityPhase 4NCT07859189
Immediate Versus Criterion-triggered Semaglutide for Suboptimal Clinical Response One Year After Primary Metabolic and Bariatric Surgery
A Phase 4 study testing Semaglutide weekly injection in people with Morbid Obesity, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
Trial summary
Roughly one patient in five never reaches the expected weight loss after MBS, and long-term regain after SG is well documented. These patients are identifiable at the 12-month visit. Today they are watched, coached, and treated only when failure is established. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Semaglutide weekly injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary laparoscopic SG or RYGB at our unit or a participating unit
- %TWL less than 20% from the day of surgery, in one of two tiers. Tier A, surgical nonresponse: below 10% TWL at the 12-month visit; eligible immediately, randomization between months 12 and 14. Tier B, suboptimal response: 10 to below 20% TWL at the 12-month visit; eligible only after a documented plateau, randomization between months 12 and 18 (Plateau, defined. Two clinic weights at least 12 weeks apart differing by less than 2% of body weight, on the trial scale, with no change in treatment between them. This sits inside the swing the consensus panel itself called normal physiologic fluctuation. A Tier B patient still losing at month 12 is re-weighed at months 15 and 18. Reaching 20% TWL at any point means a good response and no enrollment. Still below 20% at month 18 means eligible regardless of plateau; the cap stops watchful waiting from becoming neglect.)
- Anatomy assessed as normal in all: upper endoscopy for every patient, contrast study when symptoms suggest it
- Able to self-inject and consent.
Who cannot join
- Any GLP-1-based therapy since surgery
- Recurrent weight gain by the consensus definition, regain of more than 25% of the weight lost from nadir; these patients belong to RESURGE, not here
- Anatomical abnormality explaining the poor response (these patients go to the revision pathway, not this trial)
- Pregnancy or conception planned within the study (obesity pharmacotherapy is stopped at least 2 months before any planned conception, per current labeling and the 2026 Standards)
- type 1 diabetes
- medullary thyroid carcinoma or MEN2 history
- pancreatitis history
- untreated severe depression or active eating disorder on psychological review
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria, 21531
Mohamed Hany Ashour, Professor, MD, +201002600970, mohamed.ashour@alexu.edu.eg
Mohamed Hany Ashour, Professor, MD, mohamed.ashour@alexu.edu.eg
About this study
Official title: Immediate Versus Criterion-triggered Semaglutide for Suboptimal Clinical Response One Year After Primary Metabolic and Bariatric Surgery: a Randomized, Double-blind Strategy Trial
Roughly one patient in five never reaches the expected weight loss after MBS, and long-term regain after SG is well documented. These patients are identifiable at the 12-month visit. Today they are watched, coached, and treated only when failure is established.
Whether the drug works in this group is no longer the question. BARI-STEP, published this year, randomized 70 patients with less than 20% weight loss after gastric bypass (including one-anastomosis) or sleeve gastrectomy, a mean of seven years after surgery, to semaglutide 2.4 mg or placebo: 18.0% loss versus 0.4% gain at 68 weeks, an adjusted difference of 19.1 percentage points. Its population was mixed, 55.7% with recurrent weight gain and 44.3% with suboptimal initial response, and its exploratory comparison found no difference in drug response between the two presentations. BARI-OPTIMISE showed the same direction with liraglutide, as did a randomized trial after gastric banding. Efficacy is settled.
Read more
Timing is not. BARI-STEP recruited patients a mean of seven years past surgery, after failure had hardened. No trial has tested treating at first recognition, the 12-month visit, against the current standard of structured waiting. The field's own reviews name timing and duration as the open questions. The 2024 IFSO international consensus reached 100% agreement that medication after MBS should generally be withheld until the weight plateau, and 100% agreement that adding it for a suboptimal response can then improve outcomes. That is exactly our immediate arm: treat at the plateau, at first recognition. The triggered arm is what clinics actually do: wait for established failure. Both positions rest on expert agreement, not on a trial. This is the randomized test of the consensus pathway. A registered open-label pilot starts tirzepatide at 12 or 18 months but is small, unblinded, and not a strategy comparison.
The 2026 consensus draws the line for us, and this protocol respects it. The Delphi panel defined surgical nonresponse as less than 10% TWL at 12 months, defined recurrent weight gain as regain of more than 25% of lost weight from nadir, and treated a 10% swing in %EWL from nadir as normal physiologic fluctuation. It gave no 12-month label at all to the patient with 10 to 19.9% TWL, and the IFSO Delphi consensus expects the weight nadir up to 2 years after surgery (Obes Surg 2023). So a patient at 14% TWL at one year may still be on the way down, and calling that failure would be wrong. The protocol therefore splits eligibility into two tiers. Below 10% TWL at 12 months: consensus-defined nonresponse, randomized at once, waiting adds nothing. 10 to below 20% TWL: randomized only after a documented plateau, defined in Section 4, with a hard cap at month 18 so waiting cannot drift into neglect. Randomization is stratified by tier, and results are reported by tier.
Read the detailed description
Both strategies have a real case, which is what makes this a trial and not a formality. For waiting: some patients improve in the second year without any drug, the drug is expensive, and a treat-everyone-at-12-months policy is unaffordable for most health systems, certainly ours. For immediate treatment: the BARI-STEP effect size, the metabolic cost of two lost years, and the risk that established regain is harder to reverse. Genuine equipoise, between strategies rather than between drug and nothing.
The design removes the ethical problem. Nobody is denied treatment. The triggered arm receives identical lifestyle support and blinded placebo, with guaranteed open-label semaglutide the moment the Delphi recurrence criteria are met, and unconditionally 12 months after randomization if response is still suboptimal. The question the trial asks is when, never whether.
The answer also bears on the operating room. Suboptimal responders are tomorrow's conversion candidates, and conversion carries higher morbidity for around 20% additional weight loss, which is why the field is already comparing drugs against conversion retrospectively. If early drug therapy keeps patients off the revision list, that is measured here as a secondary endpoint.
The health-economic answer may matter most. The triggered strategy tells us what fraction of suboptimal responders never need the drug at all, and what a targeted policy costs per percentage point of weight loss against a treat-all policy. For Egypt and every resource-limited system, that number decides what clinics will actually do. It fits the direction of the 2024 IFSO position on combining medication with surgery while telling payers when to start paying.
- Conditions
- Morbid Obesity
- Being tested
- Semaglutide weekly injection, Placebo
- Keywords
- TOP-UP, semaglutide, suboptimal clinical response, primary metabolic and bariatric surgery, bariatric surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide weekly injectionDrug
semaglutide escalated to 2.4 mg weekly, continued for 12 months.
PlaceboDrug
Criterion-triggered strategy: matched placebo with identical lifestyle support; guaranteed open-label semaglutide the moment consensus recurrence criteria are met, and in any case 12 months after randomization if response remains suboptimal.
| Study group | Role | What they receive |
|---|---|---|
| Immediate | Active comparator | semaglutide 0.25, 0.5, 1.0, 1.7, 2.4 mg weekly in 4-weekly steps, then 2.4 mg or maximal tolerated dose, with reductions for tolerability permitted and recorded, to 12 months after randomization; in BARI-STEP six patients held reduced doses and the effect stood. Receives: Drug: Semaglutide weekly injection |
| Triggered | Placebo comparator | matched placebo on the identical schedule. Trigger 1: recurrent weight gain by the consensus definition, regain of more than 25% of the weight lost from nadir, confirmed on a second weight 4 weeks later, then immediate open-label semaglutide. Trigger 2: %TWL still below 20% at 12 months after randomization, then open-label semaglutide for the following 12 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage total weight loss
Measured in kilograms from pre-surgery weight at 12 months after randomization, same calibrated scale, morning, light clothing.
Measured: at 12 months
Secondary outcomes (6)
Percentage total weight loss
Measured in kilograms at 6 and 24 months after randomization
Measured: 6, 24 months
change in HbA1c
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
Measured: 12, 24 months
systolic and diastolic blood pressure
Normal blood pressure is less than 120 mm Hg systolic and less than 80 mm Hg diastolic. Systolic (Top Number): Measures the pressure in your arteries when your heart beats and contracts. Diastolic (Bottom Number): Measures the pressure in your arteries when your heart rests between beats. • Normal: Less than 120 mm Hg systolic and less than 80 mm Hg diastolic. • Elevated: 120-129 mm Hg systolic and less than 80 mm Hg diastolic. • Stage 1 Hypertension (High Blood Pressure): 130-139 mm Hg systolic or 80-89 mm Hg diastolic. • Stage 2 Hypertension: 140 mm Hg or higher systolic, or 90 mm Hg or higher diastolic. • Hypertensive Crisis: Higher than 180 mm Hg systolic and/or higher than 120 mm Hg diastolic. This requires immediate emergency medical care
Measured: 12, 24 months
total cholesterol, LDL, HDL, and triglycerides
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.)
Measured: 12, 24 months
Hand-grip strength
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.
Measured: 0, 12, 24 months
change in IWQOL-Lite-CT total and domain scores
The IWQOL-Lite-CT (Impact of Weight on Quality of Life-Lite Clinical Trials Version) score ranges from 0 to 100, where 100 represents the best possible quality of life and functioning (meaning zero weight-related impairment). • Total Score Range: 0-100 (higher = better quality of life) • Domain/Composite Scores: 0-100 • Raw scores are converted or transformed to a 0-100 scale for standard reporting.
Measured: 0, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859189
- Sponsor's protocol ID
- TOP-UP Trial
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Criterion-triggered Semaglutide for Suboptimal Clinical Response One Year After Primary Metabolic and Bariatric Surgery: a Randomized, Double-blind Strategy Trial
- ClinicalTrials.gov ID
- NCT07859189
- Acronym / sponsor ID
- TOP-UP Trial
- Conditions
- Morbid Obesity
- Keywords
- TOP-UP, semaglutide, suboptimal clinical response, primary metabolic and bariatric surgery, bariatric surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Roughly one patient in five never reaches the expected weight loss after MBS, and long-term regain after SG is well documented. These patients are identifiable at the 12-month visit. Today they are watched, coached, and treated only when failure is established.
Whether the drug works in this group is no longer the question. BARI-STEP, published this year, randomized 70 patients with less than 20% weight loss after gastric bypass (including one-anastomosis) or sleeve gastrectomy, a mean of seven years after surgery, to semaglutide 2.4 mg or placebo: 18.0% loss versus 0.4% gain at 68 weeks, an adjusted difference of 19.1 percentage points. Its population was mixed, 55.7% with recurrent weight gain and 44.3% with suboptimal initial response, and its exploratory comparison found no difference in drug response between the two presentations. BARI-OPTIMISE showed the same direction with liraglutide, as did a randomized trial after gastric banding. Efficacy is settled.
Timing is not. BARI-STEP recruited patients a mean of seven years past surgery, after failure had hardened. No trial has tested treating at first recognition, the 12-month visit, against the current standard of structured waiting. The field's own reviews name timing and duration as the open questions. The 2024 IFSO international consensus reached 100% agreement that medication after MBS should generally be withheld until the weight plateau, and 100% agreement that adding it for a suboptimal response can then improve outcomes. That is exactly our immediate arm: treat at the plateau, at first recognition. The triggered arm is what clinics actually do: wait for established failure. Both positions rest on expert agreement, not on a trial. This is the randomized test of the consensus pathway. A registered open-label pilot starts tirzepatide at 12 or 18 months but is small, unblinded, and not a strategy comparison.
The 2026 consensus draws the line for us, and this protocol respects it. The Delphi panel defined surgical nonresponse as less than 10% TWL at 12 months, defined recurrent weight gain as regain of more than 25% of lost weight from nadir, and treated a 10% swing in %EWL from nadir as normal physiologic fluctuation. It gave no 12-month label at all to the patient with 10 to 19.9% TWL, and the IFSO Delphi consensus expects the weight nadir up to 2 years after surgery (Obes Surg 2023). So a patient at 14% TWL at one year may still be on the way down, and calling that failure would be wrong. The protocol therefore splits eligibility into two tiers. Below 10% TWL at 12 months: consensus-defined nonresponse, randomized at once, waiting adds nothing. 10 to below 20% TWL: randomized only after a documented plateau, defined in Section 4, with a hard cap at month 18 so waiting cannot drift into neglect. Randomization is stratified by tier, and results are reported by tier.
Detailed description
Both strategies have a real case, which is what makes this a trial and not a formality. For waiting: some patients improve in the second year without any drug, the drug is expensive, and a treat-everyone-at-12-months policy is unaffordable for most health systems, certainly ours. For immediate treatment: the BARI-STEP effect size, the metabolic cost of two lost years, and the risk that established regain is harder to reverse. Genuine equipoise, between strategies rather than between drug and nothing.
The design removes the ethical problem. Nobody is denied treatment. The triggered arm receives identical lifestyle support and blinded placebo, with guaranteed open-label semaglutide the moment the Delphi recurrence criteria are met, and unconditionally 12 months after randomization if response is still suboptimal. The question the trial asks is when, never whether.
The answer also bears on the operating room. Suboptimal responders are tomorrow's conversion candidates, and conversion carries higher morbidity for around 20% additional weight loss, which is why the field is already comparing drugs against conversion retrospectively. If early drug therapy keeps patients off the revision list, that is measured here as a secondary endpoint.
The health-economic answer may matter most. The triggered strategy tells us what fraction of suboptimal responders never need the drug at all, and what a targeted policy costs per percentage point of weight loss against a treat-all policy. For Egypt and every resource-limited system, that number decides what clinics will actually do. It fits the direction of the 2024 IFSO position on combining medication with surgery while telling payers when to start paying.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate | Active comparator | Drug: Semaglutide weekly injectionsemaglutide 0.25, 0.5, 1.0, 1.7, 2.4 mg weekly in 4-weekly steps, then 2.4 mg or maximal tolerated dose, with reductions for tolerability permitted and recorded, to 12 months after randomization; in BARI-STEP six patients held reduced doses and the effect stood. |
| Triggered | Placebo comparator | Drug: Placebomatched placebo on the identical schedule. Trigger 1: recurrent weight gain by the consensus definition, regain of more than 25% of the weight lost from nadir, confirmed on a second weight 4 weeks later, then immediate open-label semaglutide. Trigger 2: %TWL still below 20% at 12 months after randomization, then open-label semaglutide for the following 12 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary laparoscopic SG or RYGB at our unit or a participating unit
- %TWL less than 20% from the day of surgery, in one of two tiers. Tier A, surgical nonresponse: below 10% TWL at the 12-month visit; eligible immediately, randomization between months 12 and 14. Tier B, suboptimal response: 10 to below 20% TWL at the 12-month visit; eligible only after a documented plateau, randomization between months 12 and 18 (Plateau, defined. Two clinic weights at least 12 weeks apart differing by less than 2% of body weight, on the trial scale, with no change in treatment between them. This sits inside the swing the consensus panel itself called normal physiologic fluctuation. A Tier B patient still losing at month 12 is re-weighed at months 15 and 18. Reaching 20% TWL at any point means a good response and no enrollment. Still below 20% at month 18 means eligible regardless of plateau; the cap stops watchful waiting from becoming neglect.)
- Anatomy assessed as normal in all: upper endoscopy for every patient, contrast study when symptoms suggest it
- Able to self-inject and consent.
Key exclusion criteria (8 listed)
- Any GLP-1-based therapy since surgery
- Recurrent weight gain by the consensus definition, regain of more than 25% of the weight lost from nadir; these patients belong to RESURGE, not here
- Anatomical abnormality explaining the poor response (these patients go to the revision pathway, not this trial)
- Pregnancy or conception planned within the study (obesity pharmacotherapy is stopped at least 2 months before any planned conception, per current labeling and the 2026 Standards)
- type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide weekly injectionsemaglutide escalated to 2.4 mg weekly, continued for 12 months. | Drug | Immediate |
| PlaceboCriterion-triggered strategy: matched placebo with identical lifestyle support; guaranteed open-label semaglutide the moment consensus recurrence criteria are met, and in any case 12 months after randomization if response remains suboptimal. | Drug | Triggered |
Primary outcome
Percentage total weight loss
Time frame: at 12 months
Measured in kilograms from pre-surgery weight at 12 months after randomization, same calibrated scale, morning, light clothing.
6 secondary outcomes
Percentage total weight loss
Time frame: 6, 24 months
change in HbA1c
Time frame: 12, 24 months
systolic and diastolic blood pressure
Time frame: 12, 24 months
total cholesterol, LDL, HDL, and triglycerides
Time frame: 12, 24 months
Hand-grip strength
Time frame: 0, 12, 24 months
change in IWQOL-Lite-CT total and domain scores
Time frame: 0, 12, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide weekly injection in people with Morbid Obesity, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Hany Ashour, Professor, MD (+201002600970, mohamed.ashour@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage total weight loss (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.