New trial aims to help people with obesity lose weight without losing muscle

NCT ID NCT06854614

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether combining anti-obesity medications with a structured lifestyle program can help people with obesity lose weight and keep muscle. 150 participants will first take tirzepatide or semaglutide for 9 months, then switch to another oral medication for 12 months. The goal is to see which sequence works best for weight loss and muscle preservation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tirzepatide, semaglutide, phentermine-topiramate, naltrexone-bupropion, orlistat
What this could lead to
If successful, this could point toward a more effective way to lose weight and maintain muscle using a sequence of anti-obesity medications.
What could go wrong
This is a relatively small, early-phase trial (150 people) and results may not apply to everyone. Side effects from the medications are possible, and the study is not designed to prove long-term safety or effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

150 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Gender: men and women 2. Ethnicity: all ethnic groups 3. Age: ≥ 25, \< 65 years 5\. Obesity, BMI ≥ 30 and BMI \< 45 6. An Employee, or the significant other of an employee, that is covered by the Cleveland Clinic Employee Health Plan Exclusion Criteria: 1. Patients with history of diabetes 2. Glomerular Filtration Rate \<30 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration Equation, CKD-EPI) 3. Current glucocorticoid therapy, except for maintenance glucocorticoid therapy of prednisone 5 mg or equivalent 4. Currently or within the past 6 months receiving an anti-obesity medication, or any other medication used for the primary intent of weight loss 5. Any condition, unwillingness, or inability, not covered by any of the other exclusion criteria, which, in the study clinician's opinion, might jeopardize the subject's safety or compliance with the protocol 6. Mental incapacity or language barrier 7. Pregnancy or plans to become pregnant within the next 2 years 8. Personal or family history of medullary thyroid carcinoma 9. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2 10. previous history of pancreatitis, history of severe liver disease (Cirrhosis), or severe disease of digestive tract 11. History of congestive heart failure 12. History of bariatric or metabolic surgery/procedure 13. Prior participation in the Endocrinology and Metabolism Institutes Integrated Weight Management Program within the past 3 months 14. Contraindication for physical activity or significant physical limitation 15. Smoking 16. Cardiovascular disease including uncontrolled hypertension, history of arrhythmias or coronary artery disease 17. History of recurrent kidney stones 18. History of glaucoma 19. History of seizure disorders 20. Uncontrolled lung disease (difficult to control Asthma or COPD) 21. Medications that affect physical performance (beta-blocker or others) 22. Uncontrolled thyroid disease 23. Patients with personal commitments that limit optimal participation 24. Concurrent use of bupropion or naltrexone or previous intolerance to any of these medic 25. Previous intolerance to use or allergy to any of the anti-obesity medications approved in this study 26. History of malabsorptive disorders or cholestasis 27. Conductive implanted devices (i.e. cardiac pacemaker, cardioverter-defibrillators)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

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