{ "method": "Hand review of ClinicalTrials.gov studies on stopping or stepping down semaglutide/tirzepatide.\nInput: ops/data/glp1-stopping/ctgov-raw.json (from ops/scripts/glp1_stopping_ctgov.py; 1,006 studies, keyword hits).\nEach keyword hit was read by hand (title, summary, arms, outcomes); the kept list and categories are below.\nSTEP 1 (NCT03548935, off-treatment extension) and STEP 4 (NCT03548987) were added by hand: their registry text\ndoes not use stopping/withdrawal words, so the keyword pass missed them.\nRe-fetches each kept record for live status/results, extracts posted results for NCT05548647 (Study 2) and NCT06640972,\nand writes site/research/sources/glp1-stopping-ctgov-2026-10-19.json. Jabbit analysis, 2026-10-19 (ET).", "summary": { "pulled_et": "2026-10-19 06:05 EDT", "ctgov_unique_semaglutide_or_tirzepatide_studies": 1006, "keyword_hits_read_by_hand": 119, "strategy_trials": 18, "strategy_by_category": { "step_down": 7, "switch": 3, "add_on": 8 }, "strategy_with_posted_results": [ "NCT06640972" ], "strategy_completed": [ "NCT06047548", "NCT06584916", "NCT06605703", "NCT06221696", "NCT06640972" ], "taper_to_zero_vs_abrupt_stop": [ "NCT07294950", "NCT07859176" ], "taper_to_zero_vs_abrupt_stop_status": { "NCT07294950": "RECRUITING", "NCT07859176": "NOT_YET_RECRUITING" }, "all_reviewed_measuring_appetite_or_food_thoughts_after_stopping": [ "NCT07859176", "NCT06605703", "NCT06221696", "NCT06734312", "NCT07101939", "NCT05548647", "NCT07387796", "NCT06856928" ], "appetite_after_stopping_with_posted_results": [ "NCT05548647" ] }, "studies": [ { "nct": "NCT06047548", "category": "step_down", "what": "SURMOUNT-MAINTAIN: tirzepatide MTD vs reduce to 5 mg vs placebo for 52 weeks after 60 weeks on MTD", "title": "A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities", "sponsor": "Eli Lilly and Company", "status": "COMPLETED", "start": "2023-09-20", "enrollment": 441, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT07294950", "category": "step_down", "what": "REST: semaglutide cut 25% every 4 weeks to zero over 16 weeks vs stopping at once", "title": "Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: Recovery Effects After Semaglutide Termination", "sponsor": "Mount Sinai Hospital, Canada", "status": "RECRUITING", "start": "2026-02-01", "enrollment": 98, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT07859176", "category": "step_down", "what": "Semaglutide taper (1.7, 1.0, 0.5, 0.25 mg, 4 weeks each) vs abrupt stop with matched placebo pens, after bariatric surgery", "title": "Tapered Versus Abrupt Discontinuation of Semaglutide After Treatment of Recurrent Weight Gain or Suboptimal Response Following Metabolic and Bariatric Surgery", "sponsor": "General Committee of Teaching Hospitals and Institutes, Egypt", "status": "NOT_YET_RECRUITING", "start": "2026-10", "enrollment": 100, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": true, "in_keyword_pass": true }, { "nct": "NCT07783854", "category": "step_down", "what": "Semaglutide 1.7 mg cut 25% every 8 weeks vs staying on 1.7 mg, 24 weeks", "title": "A Randomized Controlled Study of Dose-tapering Regimen of Semaglutide for Weight-Loss Maintenance in Adults With Overweight or Obesity", "sponsor": "Union Hospital, Tongji Medical College, Huazhong University of Science and Technology", "status": "NOT_YET_RECRUITING", "start": "2026-09-01", "enrollment": 72, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT07832084", "category": "step_down", "what": "Full-dose GLP-1 vs lower dose every other week vs switch to phentermine/topiramate", "title": "Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1s", "sponsor": "Jing Luo", "status": "NOT_YET_RECRUITING", "start": "2026-11-01", "enrollment": 60, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT07325500", "category": "step_down", "what": "Semaglutide 0.5 mg weekly 'microdose' vs no drug after 12-week induction, adults with HIV", "title": "Incretin Microdosing for Cardiometabolic Health in People With HIV", "sponsor": "The University of Texas Health Science Center, Houston", "status": "RECRUITING", "start": "2026-02-12", "enrollment": 30, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT07555730", "category": "step_down", "what": "Tirzepatide 5 mg vs AI-assisted lifestyle program after 20 weeks on MTD, type 2 diabetes", "title": "AI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With Type 2 Diabetes (AIM-MAINTAIN)", "sponsor": "Huazhong University of Science and Technology", "status": "NOT_YET_RECRUITING", "start": "2026-04-30", "enrollment": 400, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT06584916", "category": "switch", "what": "ATTAIN-MAINTAIN: switch from Wegovy or Zepbound to orforglipron (Foundayo) pill vs placebo", "title": "A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)", "sponsor": "Eli Lilly and Company", "status": "COMPLETED", "start": "2024-09-13", "enrollment": 376, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT07845500", "category": "switch", "what": "Switch from semaglutide or tirzepatide to monthly berobenatide (Pfizer) vs staying on", "title": "A Study to Learn About Switching to a Monthly Study Medicine Called Berobenatide (PF-08653944) to Help Keep Weight Off in People With Overweight or Obesity", "sponsor": "Pfizer", "status": "RECRUITING", "start": "2026-09-30", "enrollment": 660, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT06605703", "category": "switch", "what": "WW Clinic after stopping semaglutide/tirzepatide: behavioral support with vs without other medicines", "title": "A Randomized Controlled Trial Comparing the Effectiveness of Different Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide (GLP1 Transition Trial)", "sponsor": "WW International Inc", "status": "COMPLETED", "start": "2024-09-18", "enrollment": 226, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": true, "in_keyword_pass": true }, { "nct": "NCT07092618", "category": "add_on", "what": "Gradual taper in all arms plus metformin, metformin+rapamycin or metformin+low-dose naltrexone vs vitamin C", "title": "Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation", "sponsor": "AgelessRx", "status": "RECRUITING", "start": "2024-12-17", "enrollment": 150, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT06221696", "category": "add_on", "what": "Fiber supplement (glucomannan, inulin, psyllium) vs placebo after a semaglutide course", "title": "Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways)", "sponsor": "S.LAB (SOLOWAYS)", "status": "COMPLETED", "start": "2023-06-12", "enrollment": 160, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": true, "in_keyword_pass": true }, { "nct": "NCT07711548", "category": "add_on", "what": "Two diet programs for 12 months after semaglutide", "title": "Can Two Dietary Interventions Maintain Weight Loss for 12 Months After GLP-1 Therapy in Adults With Overweight/Obesity?", "sponsor": "Knut Mai", "status": "NOT_YET_RECRUITING", "start": "2027-03", "enrollment": 292, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT07091500", "category": "add_on", "what": "Semaglutide with vs without exercise training, with a 52-week follow-up after the drug", "title": "Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Therapy and Exercise Training in People With Obesity", "sponsor": "Washington University School of Medicine", "status": "RECRUITING", "start": "2025-08-11", "enrollment": 40, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT06484114", "category": "add_on", "what": "REMAIN-1: duodenal mucosal resurfacing (Revita) vs sham after >=15% loss on tirzepatide", "title": "Evaluation of the Safety and Efficacy of Revita® DMR on Body Weight Maintenance in Subjects With Obesity Who Have Achieved at Least 15% Weight Loss on Tirzepatide", "sponsor": "Fractyl Health Inc.", "status": "ACTIVE_NOT_RECRUITING", "start": "2024-09-01", "enrollment": 315, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT06734312", "category": "add_on", "what": "Gastric fundal mucosal ablation after stopping semaglutide or tirzepatide (single arm)", "title": "MAINTAIN (Mucosal AblatIoN Therapy After INcretins)", "sponsor": "Dr. Christopher McGowan", "status": "RECRUITING", "start": "2025-01-01", "enrollment": 20, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": true, "in_keyword_pass": true }, { "nct": "NCT06640972", "category": "add_on", "what": "RDX-002 vs placebo for 12 weeks in people who just stopped semaglutide or tirzepatide", "title": "Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists", "sponsor": "Response Pharmaceuticals", "status": "COMPLETED", "start": "2024-09-27", "enrollment": 68, "has_results": true, "results_first_posted": "2026-07-02", "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT07101939", "category": "add_on", "what": "PROACT 2: (S)-pindolol vs placebo for lean mass after semaglutide stops", "title": "A Study of the Effect of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass (LBM) in Obese Patents During (PROACT 1), and Post-semaglutide Therapy (PROACT 2)", "sponsor": "Actimed Therapeutics Ltd", "status": "RECRUITING", "start": "2025-06-23", "enrollment": 120, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": true, "in_keyword_pass": true }, { "nct": "NCT03548935", "category": "withdrawal", "what": "STEP 1 with 1-year off-treatment extension (added by hand)", "title": "STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity", "sponsor": "Novo Nordisk A/S", "status": "COMPLETED", "start": "2018-06-04", "enrollment": 1961, "has_results": true, "results_first_posted": "2021-08-11", "measures_appetite_or_food_thoughts": false, "in_keyword_pass": false }, { "nct": "NCT03548987", "category": "withdrawal", "what": "STEP 4: semaglutide continued vs switched to placebo after 20 weeks (added by hand)", "title": "Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity", "sponsor": "Novo Nordisk A/S", "status": "COMPLETED", "start": "2018-06-04", "enrollment": 902, "has_results": true, "results_first_posted": "2021-03-15", "measures_appetite_or_food_thoughts": false, "in_keyword_pass": false }, { "nct": "NCT04660643", "category": "withdrawal", "what": "SURMOUNT-4: tirzepatide continued vs switched to placebo after 36 weeks", "title": "A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss", "sponsor": "Eli Lilly and Company", "status": "COMPLETED", "start": "2021-03-29", "enrollment": 783, "has_results": true, "results_first_posted": "2024-05-22", "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true }, { "nct": "NCT05548647", "category": "withdrawal", "what": "Penn appetite trial: semaglutide 60 weeks, then 12-week switch to placebo (Study 2)", "title": "Semaglutide Treatment, Appetite, and Eating Behavior: Long-term Effects", "sponsor": "University of Pennsylvania", "status": "COMPLETED", "start": "2022-07-26", "enrollment": 120, "has_results": true, "results_first_posted": "2026-08-03", "measures_appetite_or_food_thoughts": true, "in_keyword_pass": true }, { "nct": "NCT07387796", "category": "physiology", "what": "3-4 week tirzepatide pause and restart: food-cue brain response, cravings, intrusive food thoughts", "title": "Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation", "sponsor": "The University of Texas at Dallas", "status": "RECRUITING", "start": "2026-10", "enrollment": 40, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": true, "in_keyword_pass": true }, { "nct": "NCT06856928", "category": "physiology", "what": "Meal-challenge appetite and hormones before and after stopping semaglutide or tirzepatide", "title": "Impact of Antiobesity Medications on Appetite and Appetite-related Hormones and Metabolites.", "sponsor": "University of Colorado, Denver", "status": "NOT_YET_RECRUITING", "start": "2025-03", "enrollment": 16, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": true, "in_keyword_pass": true }, { "nct": "NCT06801015", "category": "physiology", "what": "Gastric emptying on semaglutide or tirzepatide and 4 weeks after stopping", "title": "Effects of Long-Acting GLP-1 (Glucagon-like Peptide-1) or Dual Incretin (GLP-1 and GIP [Glucose-dependent Insulinotropic Peptide]) Modulation on Gastric Motor Functions", "sponsor": "Mayo Clinic", "status": "ACTIVE_NOT_RECRUITING", "start": "2025-10-01", "enrollment": 30, "has_results": false, "results_first_posted": null, "measures_appetite_or_food_thoughts": false, "in_keyword_pass": true } ], "posted_results": { "NCT05548647_study2_week72": { "Study 2 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)": { "unit": "kcal", "time_frame": "S2: Endpoint comparison at week 72", "param": "MEAN", "values": { "Continuous Placebo (Weeks 60-72)": "1073.0", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "951.8", "Continued Medication (Semaglutide) (Weeks 60-72)": "657.7" }, "description": "Primary outcome (Study 2)", "n": { "Continuous Placebo (Weeks 60-72)": "20", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "43", "Continued Medication (Semaglutide) (Weeks 60-72)": "10" }, "p": [ "0.1513" ] }, "Study 2 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)": { "unit": "mm", "time_frame": "S2: Week 72 endpoint controlling for S1 baseline", "param": "MEAN", "values": { "Continuous Placebo (Weeks 60-72)": "48.5", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "63.6", "Continued Medication (Semaglutide) (Weeks 60-72)": "38.5" }, "description": "Secondary confirmatory outcome (Study 2): Visual analogue scale rating of hunger during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater hunger.", "n": { "Continuous Placebo (Weeks 60-72)": "20", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "43", "Continued Medication (Semaglutide) (Weeks 60-72)": "10" }, "p": [ "0.0196" ] }, "Study 2 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)": { "unit": "mm", "time_frame": "S2: Week 72 endpoint controlling for S1 baseline", "param": "MEAN", "values": { "Continuous Placebo (Weeks 60-72)": "57.4", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "59.4", "Continued Medication (Semaglutide) (Weeks 60-72)": "76.7" }, "description": "Secondary confirmatory outcome (Study 2): Visual analogue scale rating of fullness after meals during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater fullness after meals.", "n": { "Continuous Placebo (Weeks 60-72)": "20", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "43", "Continued Medication (Semaglutide) (Weeks 60-72)": "10" }, "p": [ "0.7407" ] }, "Study 2 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)": { "unit": "mm", "time_frame": "S2: Week 72 endpoint controlling for S1 baseline", "param": "MEAN", "values": { "Continuous Placebo (Weeks 60-72)": "42.7", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "62.9", "Continued Medication (Semaglutide) (Weeks 60-72)": "26.4" }, "description": "Secondary confirmatory outcome (Study 2): Visual analogue scale rating of food preoccupation during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater food preoccupation.", "n": { "Continuous Placebo (Weeks 60-72)": "20", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "43", "Continued Medication (Semaglutide) (Weeks 60-72)": "10" }, "p": [ "0.0017" ] }, "Study 2 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)": { "unit": "Units on a scale", "time_frame": "S2: Week 72 endpoint controlling for S1 baseline", "param": "MEAN", "values": { "Continuous Placebo (Weeks 60-72)": "2.1", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "2.5", "Continued Medication (Semaglutide) (Weeks 60-72)": "1.7" }, "description": "Secondary confirmatory outcome (Study 2): Explicit responsiveness to the food environment measured by the summary score of the Power of Food Scale (15-item version). Score range 1-5. Higher scores indicate greater responsiveness to the food environment.", "n": { "Continuous Placebo (Weeks 60-72)": "20", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "43", "Continued Medication (Semaglutide) (Weeks 60-72)": "10" }, "p": [ "0.1237" ] }, "Study 2 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task": { "unit": "Units on a scale", "time_frame": "S2: Week 72 endpoint controlling for S1 baseline", "param": "MEAN", "values": { "Continuous Placebo (Weeks 60-72)": "4.6", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "-7.2", "Continued Medication (Semaglutide) (Weeks 60-72)": "-2.9" }, "description": "Secondary confirmatory outcome (Study 2): Implicit food wanting of high-fat, savory foods measured using the Leeds Food Preference Task. Scores range from -100 to +100 with higher scores indicating a greater implicit wanting of high-fat savory foods.", "n": { "Continuous Placebo (Weeks 60-72)": "20", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "43", "Continued Medication (Semaglutide) (Weeks 60-72)": "10" }, "p": [ "0.044" ] }, "Study 2 Body Weight (kg)": { "unit": "kg", "time_frame": "S2: Week 72 endpoint controlling for S1 baseline", "param": "MEAN", "values": { "Continuous Placebo (Weeks 60-72)": "98.3", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "88.9", "Continued Medication (Semaglutide) (Weeks 60-72)": "85.3" }, "description": "Supportive secondary outcome (Study 2): Body weight (kg) at week 72", "n": { "Continuous Placebo (Weeks 60-72)": "20", "Medication (Semaglutide) Switched to Placebo (Weeks 60-72)": "43", "Continued Medication (Semaglutide) (Weeks 60-72)": "10" }, "p": [ "<0.001" ] } }, "NCT06640972_week12": { "Incremental Postprandial Triglycerides (TG)": { "unit": "percent change", "time_frame": "12 weeks", "param": "MEAN", "values": { "Investigational Drug": "-51.91", "Placebo": "43.81" }, "description": "Mean percent change in incremental TG area under the curve (AUC) from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.", "n": { "Investigational Drug": "34", "Placebo": "34" }, "p": [] }, "Body Weight": { "unit": "Percent change", "time_frame": "12 weeks", "param": "MEAN", "values": { "Investigational Drug": "5.710", "Placebo": "8.364" }, "description": "Mean percent change in body weight from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.", "n": { "Investigational Drug": "34", "Placebo": "34" }, "p": [] }, "5% Increase in Body Weight": { "unit": "Participants", "time_frame": "12 weeks", "param": "COUNT_OF_PARTICIPANTS", "values": { "At least a 5% change: Investigational Drug": "19", "At least a 5% change: Placebo": "24", "No 5% change: Investigational Drug": "15", "No 5% change: Placebo": "10" }, "description": "Percentage of patients exhibiting at least a 5% increase from baseline to Week 12.", "n": { "Investigational Drug": "34", "Placebo": "34" }, "p": [] }, "LDL-C": { "unit": "Percent change", "time_frame": "12 weeks", "param": "MEAN", "values": { "Investigational Drug": "3.13", "Placebo": "6.50" }, "description": "Mean percent change from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.", "n": { "Investigational Drug": "34", "Placebo": "34" }, "p": [] } } }, "notes": [ "Keyword searches can miss studies whose registry text never says stop, withdraw, taper or maintain (STEP 1 and STEP 4 were added by hand for that reason).", "Excluded keyword hits: stopping smoking or alcohol, pausing the drug before surgery or endoscopy, bariatric-surgery regain treated with a GLP-1, other drugs' maintenance trials, and studies where 'maintenance' meant the maintenance dose." ] }