← Trials/Trial dossier/NCT07517042

RecruitingPhase NA

ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management

Achieving Sustained Weight Control Via Exercise, Nutrition & Drugs (Mazdutide) (ASCEND- 1 Trial)

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

NCT IDNCT07517042
Org study IDB2025-712

Timeline

Milestones

Study first posted2026-04-08actual
Last update posted2026-04-08actual
Study start2026-04estimated (month precision)
Primary completion2028-12estimated (month precision)
Study completion2028-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Adult men or women aged 18 years or older;
Simple obesity, defined as a body mass index (BMI) of 28.0-45.0 kg/m²;
Able and willing to provide written informed consent.

Exclusion criteria

Active pulmonary tuberculosis, malignant tumors, human immunodeficiency virus (HIV) infection, or other serious infectious or systemic diseases;
Severe hepatic impairment (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >3 times the upper limit of normal), severe renal impairment, or end-stage renal disease (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m²);
Severe cardiovascular diseases, including angina pectoris, myocardial infarction, or stroke within the past 6 months;
Severe gastrointestinal diseases, or a history of gastrointestinal resection surgery within the past year;
Acute or chronic pancreatitis, gallbladder disease, or pancreatic injury;
Obesity secondary to other causes, including Cushing's syndrome, primary hypothyroidism, hypothalamic obesity, or acromegaly; drug-induced obesity, such as obesity related to the use of antipsychotic agents or glucocorticoids;
Current smoker or habitual smoking within the past 3 months;
Current use of other weight-loss medications or a history of bariatric surgery;
Previously diagnosed diabetes mellitus or current use of glucose-lowering medications;
Pregnant or breastfeeding women, or women planning pregnancy during the study period;
Inability to complete a 2-year follow-up due to health conditions, relocation, or other reasons;
Any other condition deemed by the investigator to make the participant unsuitable for participation in the study.

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
Glycemic / diabetes
3
Cardiometabolic biomarkers
3
Patient-reported / QoL
2
MASH / liver
1

Weight & body composition

5 endpoints
Primary/protocol endpoint

Percentage change of body weight

Time frame:From randomization to Week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index (BMI)

Time frame:From randomization to Week 52

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From randomization to Week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in total body fat

Time frame:From randomization to Week 52

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change in abdominal visceral fat area

Time frame:From randomization to Week 52

Visceral fat, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint/low confidence

Changes in blood glucose

Time frame:From randomization to Week 52

change from baseline, improvement

Secondary/protocol endpoint

Changes in insulin sensitivity

Time frame:From randomization to Week 52

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Changes in pancreatic β-cell function

Time frame:From randomization to Week 52

change from baseline, improvement

MASH / liver

1 endpoint
Secondary/protocol endpoint

Change in hepatic fat content

Time frame:From randomization to Week 52

Liver fat content, change

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change in blood pressure

Time frame:From randomization to Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in serum lipid profile

Time frame:From randomization to Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in pulse wave velocity (PWV)

Time frame:From randomization to Week 52

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)

Time frame:From randomization to Week 52

change from baseline, improvement

Secondary/protocol endpoint

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.