HARMONY

Not yet recruitingPhase NA

Incretin-based Therapies, Nutrition, and Physical Activity

Holistic Approach to Cardiometabolic Health and Obesity: Incretin-based Therapies, Nutrition, and Active Lifestyle

Lead sponsor

Laval University

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Estimated enrollment

120

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoints

•Changes in muscle mass (bioimpedance scale)•Changes in muscular function (handgrip strength)•Changes in muscular function

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07409831

Org study ID2026-4477

Timeline

Milestones

Study first posted2026-02-13actual

Last update posted2026-02-13actual

Study start2026-03estimated (month precision)

Primary completion2028-03estimated (month precision)

Study completion2028-03estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Adults aged 18 to 70 years

•Prescribed, but not yet initiated, incretin-based pharmacotherapy [e.g., GLP-1 receptor agonist or dual GIP/GLP1 agonist] living with obesity, defined as:

-BMI >30 kg/m2, or

-BMI >27 kg/m2 with presence of comorbidities (e.g., type II diabetes, hypertension, hypercholesterolemia)

Exclusion criteria

•Medical contraindications to physical activity practice (e.g., unstable cardiovascular disease, severe orthopedic limitation)

•Prior or ongoing incretin-based therapy or history of bariatric surgery

•Pregnancy, current breastfeeding or planned pregnancy during the study period

•Implemented medical devices (e.g. pacemaker, defibrillator)

•Chronic conditions affecting protein metabolism or nutrition (e.g., advanced kidney disease, active cancer)

Endpoints (25)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Weight & body composition

MASH / liver

Patient-reported / QoL

Other clinical outcomes

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Changes in body composition (bioimpedance scale)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Secondary/protocol endpoint

Changes in body mass index (bioimpedance scale)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Secondary/protocol endpoint

Changes in visceral fat levels (bioimpedence scale)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Changes in glycemic profiles (blood sample)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

MASH / liver

3 endpoints

Secondary/protocol endpoint

Changes in hepatic biomarkers (blood sample)

Time frame:Baseline to 6 months and baseline to12 months

descriptive

Secondary/protocol endpoint

Changes in hepatic steatosis (transcient elastography)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Secondary/protocol endpoint

Changes in hepatic fibrosis (transcient elastography)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Changes in lipid profiles (blood sample)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Patient-reported / QoL

3 endpoints

Secondary/protocol endpoint

Changes in eating behaviors (Adult Eating Behaviour Questionnaire)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Secondary/protocol endpoint

Changes in well-being, mood and Quality of Life (QLaval)

Time frame:Baseline to 12 months

descriptive

Secondary/protocol endpoint

Feasibility of care model (satisfaction questionnaire)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Feasibility of care model (adherence)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Secondary/protocol endpoint

Feasibility of care model (rentention)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Other (unclassified)

12 endpoints

Primary/protocol endpoint/low confidence

Changes in muscle mass (bioimpedance scale)

Time frame:Baseline to 6 months

descriptive

Primary/protocol endpoint/low confidence

Changes in muscular function (handgrip strength)

Time frame:Baseline to 6 months

descriptive

Primary/protocol endpoint/low confidence

Changes in muscular function (short physical performance battery)

Time frame:Baseline to 6 months

descriptive

Secondary/protocol endpoint/low confidence

Changes in muscle mass (bioimpedance scale)

Time frame:Baseline to 12 months

descriptive

Secondary/protocol endpoint/low confidence

Changes in muscular function (handgrip strength)

Time frame:Baseline to 12 months

descriptive

Secondary/protocol endpoint/low confidence

Changes in muscular function (short physical performance battery)

Time frame:Baseline to 12 months

descriptive

Secondary/protocol endpoint/low confidence

Changes in nutrional intakes (Web-based 24-hour dietary recall)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Secondary/protocol endpoint/low confidence

Changes in diet quality (Web-based 24-hour dietary recall)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Secondary/protocol endpoint/low confidence

Changes in hemodynamic measurements (sphygmomanometer)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Secondary/protocol endpoint/low confidence

Changes in physical activity participation (three-day physical activity record)

Time frame:Baseline to 6 months and baseline to12 months

descriptive

Secondary/protocol endpoint/low confidence

Changes in physical activity participation (step count)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Secondary/protocol endpoint/low confidence

Changes in physical activity participation (exercise facility participation)

Time frame:Baseline to 6 months and baseline to 12 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.