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HomeTrials › NCT07729332

Obesity & weight · Phase 4 · Opening soon

Switching to Oral Weight Management Pharmacotherapy to Prevent Weight Regain After GLP-1 Therapy Discontinuation

NCT07729332 · Sponsor: Massachusetts General Hospital

What this trial means for you

This study is opening soon at 1 US site. It's studying Phentermine Pill, Orforglipron for obesity.

Who can joinAll sexes, 18 Years – 80 Years
Healthy volunteersNo, diagnosis required
What you'd takePhentermine Pill, Orforglipron
Study length~4.8 years overall
Planned participants60
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

This study will compare the effect of orforglipron and phentermine on weight maintenance.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion Criteria: 1. Age 18-80 years at screening 2. History of BMI ≥30 kg/m² 3. Current or recent (within 8 weeks) treatment with injectable semaglutide, tirzepatide, or similar GLP-1 based medication 4. Achieved ≥10% body weight loss since initiation of injectable semaglutide, tirzepatide or similar GLP-1 based medication 5. Willing to participate in the study after reviewing study infographic and confirming understanding of randomization and study procedures 6. Ability to understand and the willingness to sign a written informed consent document 7. Residence in Massachusetts Exclusion Criteria: 1. Current type 2 diabetes mellitus 2. Recent or planned surgical obesity treatment (bariatric surgery \>1 year prior to GLP-1 initiation allowed) 3. Pregnancy, intent to become pregnant, or current breastfeeding (participants of childbearing potential must have a negative pregnancy test at baseline) 4. History of pancreatitis 5. History of transplanted organ (corneal transplants permitted) or awaiting organ transplant 6. Obesity induced by endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenic/syndromic obesity (e.g., MC4R deficiency, Prader-Willi syndrome) 7. History of significant active or unstable major depressive disorder or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, serious mood or anxiety disorder) within the past 2 years 8. Any history of a suicide attempt 9. Systemic glucocorticoid therapy \>2 weeks within the prior 3 months, or anticipated need within the next 12 months 10. Use of medications known to cause significant weight gain (e.g., olanzapine, lithium) within the last 3 months. 11. Quit using nicotine-containing products less than 6 months prior to baseline visit or intention to quit use in the next year 12. Current use strong CYP3A4 inducer medications (which may include: phenytoin, carbamazepine, phenobarbital, primidone, lumacaftor, midostaurin, and pentobarbital). 13. Use of prescription or over-the-counter weight loss medications within the last 3 months, other than semaglutide, tirzepatide, or other injectable GLP-1 medication 14. Chronic kidney disease stage 3b or lower (eGFR \<45 mL/min/1.73m²) 15. Acute hepatitis or liver failure/cirrhosis 16. Known contraindications to phentermine: 1. History of coronary artery, cerebrovascular or peripheral arterial disease including myocardial infarction, unstable angina, revascularization, stroke/TIA, carotid intervention, claudication 2. Poorly-controlled blood pressure (\>149/94) or elevated heart rate (\>110 bpm) 3. History of cardiac arrhythmia 4. History of valvular heart disease 5. Congestive heart failure (any history or current) 6. Active / currently-treated hyperthyroidism (thyroid function screening required if pulse\>100) 7. History of glaucoma or been told by an ophthalmologist that you are at high risk for glaucoma 8. Heavy alcohol use within the last 6 months (men: more than 4 drinks on any day or more than 14 drinks per week; women: more than 3 drinks on any day or more than 7 drinks per week) 9. History of substance use disorder or active use of illicit substances within the last 12 months. Tetrahydrocannabinol (THC)-containing products will not be considered an illicit substance. (e.g., uncontrolled hypertension, active/unstable cardiovascular disease, arrhythmia, hyperthyroidism \[thyroid function screening required if pulse\>100\], glaucoma, history of substance use disorder 16\. Use of any stimulant medications. 17. Known contraindication to orforglipron (e.g., personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2). 18\. Any condition (e.g., drug or alcohol abuse, diagnosed eating disorder, other psychiatric disorder) that in the investigator's opinion may preclude protocol compliance

Study sites by state

Massachusetts

  • Massachusetts General Hospital, Boston

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently, so always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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