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ACTIVE NOT RECRUITING
NCT06854614
PHASE4

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

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

Summary

This is a prospective, pragmatic, 21 month, single-center, randomized, 2-phased, open-label, parallel-group trial comparing the use of enhanced lifestyle changes (ELC) in two different therapy: sequential vs continuation of AOM. The ELC consists of a medically supervised and comprehensive weight loss program (Cleveland Clinic's Department of Endocrinology, Diabetes and Metabolism's Integrated Weight Management Program). In the first phase (9 months) of the study, all participants will receive Tirzepatide 15 mg (option #1) or Semaglutide 2.4 mg if Tirzepatide is not tolerated. In the second phase, after completing 9 months of Tirzepatide or Semaglutide, participants will continue ELC and will be randomly assigned to an AOM therapy for another 12 months: group 1 (phentermine-topiramate or naltrexone-bupropion) or continuation of the same therapy of the first 9 months - group 2 (Tirzepatide or Semaglutide) The primary endpoint will be the percentage weight loss at 21 months compared to weight loss at 9 months. The goal will be to show superiority of the arm receiving ELC plus continuation of Tirzepatide or Semaglutide when compared to the other AOM therapy group (phentermine-topiramate or naltrexone-bupropion). Secondary and exploratory endpoints will include percentage of fat mass loss, lean muscle mass, functional capacity, muscle strength and compliance to enhanced lifestyle changes. IRB approval of the study will be obtained. Informed consent will be obtained.

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-03-01

Completion Date

2028-04-28

Last Updated

2026-09-30

Healthy Volunteers

No

Conditions

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

Tirzepatide

Medication for chronic weight management (Rx)

DRUG

Naltrexone-Bupropion

Medication for chronic weight management (Rx)

DRUG

Phentermine-Topiramate

Medication for chronic weight management (Rx)

DRUG

Semaglutide (Wegovy®)

Medication for chronic weight management (Rx)

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States