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LETHE
CompletedPhase NAWeight Loss With Intensive Lifestyle Modifications Plus Bariatric Surgery Versus Liraglutide 3 mg
Intensive Lifestyle Modifications With or Without Liraglutide 3 mg Versus Sleeve Gastrectomy: A 3 Arm Randomized Controlled Pilot Study (LETHE)
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
75
actual
Study population
Bariatric Surgery Candidate, Obesity / overweight
Key I/E criterion
•BMI ≥35
Primary endpoint
•BMI, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Age ranging from 18 to 70 years, stable body weight in the previous 6 months body mass index (BMI expressed in kg/m2) >35 if comorbidity (hypertension, sleep apnea, severe hip or knee arthritis) are present or >40 kg/m2.
Exclusion criteria
Type 1 or 2 diabetes, previous bariatric surgery, a history of pancreatitis, a history of major depressive or other severe psychiatric disorders, a family or personal history of multiple endocrine cancer type 2 or familial medullary thyroid carcinoma.
Endpoints (7)
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
Weight & body composition
2 endpointsChange of baseline BMI
Time frame:1 year
BMI, change
percent change from baseline, improvement
changes in body composition
Time frame:1 year
percent change from baseline, improvement
Glycemic / diabetes
2 endpointschanges in plasma glucose
Time frame:1 year
percent change from baseline, improvement
changes in HOMA-IR
Time frame:1 year
HOMA-IR (insulin sensitivity)
percent change from baseline, improvement
Cardiometabolic biomarkers
2 endpointschanges in blood pressure
Time frame:1 year
percent change from baseline, improvement
changes in lipid profile
Time frame:1 year
percent change from baseline, improvement
Other (unclassified)
1 endpointchanges of baseline weight plasma
Time frame:1 year
percent change from baseline, descriptive
Provenance
Sources
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 1, 2026 snapshot.