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ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management
Achieving Sustained Weight Control Via Exercise, Nutrition & Drugs (Mazdutide) (ASCEND- 1 Trial)
Lead sponsor
Asset
Mazdutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
13
Recruiting sites
13
Enrollment
420
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI 28-45
Primary endpoint
•Body weight, % 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
Exclusion criteria
Endpoints (14)
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
5 endpointsPercentage change of body weight
Time frame:From randomization to Week 52
Body weight, % change
percent change from baseline, improvement
Change in body mass index (BMI)
Time frame:From randomization to Week 52
BMI, change
change from baseline, improvement
Change in waist circumference
Time frame:From randomization to Week 52
Waist circumference, change
change from baseline, improvement
Change in total body fat
Time frame:From randomization to Week 52
Total fat mass
change from baseline, improvement
Change in abdominal visceral fat area
Time frame:From randomization to Week 52
Visceral fat, change
change from baseline, improvement
Glycemic / diabetes
3 endpointsChanges in blood glucose
Time frame:From randomization to Week 52
change from baseline, improvement
Changes in insulin sensitivity
Time frame:From randomization to Week 52
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Changes in pancreatic β-cell function
Time frame:From randomization to Week 52
change from baseline, improvement
MASH / liver
1 endpointChange in hepatic fat content
Time frame:From randomization to Week 52
Liver fat content, change
change from baseline, improvement
Cardiometabolic biomarkers
3 endpointsChange in blood pressure
Time frame:From randomization to Week 52
change from baseline, improvement
Change in serum lipid profile
Time frame:From randomization to Week 52
change from baseline, improvement
Change in pulse wave velocity (PWV)
Time frame:From randomization to Week 52
change from baseline, improvement
Patient-reported / QoL
2 endpointsQuality of sleep measured by the Pittsburgh sleep quality index (PSQI)
Time frame:From randomization to Week 52
change from baseline, improvement
Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
Time frame:From randomization to Week 52
descriptive, improvement
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.