Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)

PHASE4RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Obesity
Interventions
OTHER

Comprehensive weight loss

Shared Medical Appointments

OTHER

Enhanced lifestyle changes

Subjects will also be referred to an exercise physiologist for a personalized physical activity program. Physical Activity and Exercise will be discussed during SMAs as well and individually as needed for exercise progression The participants exercise prescription will be individualized based on an initial assessment. Exercise duration and progression will be recommended at the discretion of staff and exercise physiologist. The exercise program will be structured but flexible, which means patients can substitute group exercises with individual exercise if necessary, following the FITT-VP format (frequency, intensity, time, type, volume and progression). Patients can reduce exercise frequency if the duration is prolonged, or intensity is increased. Investigators will encourage patients to use Cleveland Clinic gyms across the enterprise.

DRUG

Phentermine-Topiramate

Medication for chronic weight management (Rx)

DRUG

Naltrexone-Bupropion Combination

Medication for chronic weight management (Rx)

DRUG

Orlistat

Medication for chronic weight management (Rx)

Trial Locations (1)

44195

RECRUITING

Cleveland Clinic, Cleveland

All Listed Sponsors
lead

The Cleveland Clinic

OTHER