ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
Obesity is a chronic, progressive, and relapsing disease. Although lifestyle interventions and anti-obesity medications are effective for inducing weight loss, evidence regarding their role in long-term weight maintenance after pharmacologically induced weight reduction remains limited. In addition, the high cost and potential adverse effects of weight-loss medications restrict their prolonged use, and it is unclear whether low dose medication, intensive life style intervention or together can serve as an effective strategy for weight maintenance.
This randomized controlled trial aims to evaluate the effectiveness of a 1-year intensive lifestyle intervention, a reduced dose of mazdutide (3.0 mg once weekly), or their combination in weight maintenance among individuals with obesity who have achieved initial weight loss after intensive treatment with high dose mazdutide. The study seeks to provide high-quality clinical evidence to inform long-term weight maintenance strategies after weight loss in patients with obesity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Mazdutide
DrugMazdutide is administered subcutaneously at 3.0 mg once weekly for 52 weeks during the weight maintenance period.
Intensive Lifestyle Intervention
BehavioralA structured intensive lifestyle intervention including individualized dietary counseling, physical activity guidance, and behavioral modification support for 52 weeks during the weight maintenance period.
Treatment groups
420 Participants
are divided into 4 treatment groupsGroup A: Placebo plus Intensive Lifestyle InterventionExperimental treatment 1 intervention
Group B: MazdutideExperimental treatment 1 intervention
Group C: Mazdutide Plus Intensive Lifestyle InterventionExperimental treatment 2 interventions
Group D: Standard Health Education (Control)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Percentage change of body weight
Time frame
From randomization to Week 52Secondary outcomes
1
Change in body mass index (BMI)
Time frame
From randomization to Week 522
Change in waist circumference
Time frame
From randomization to Week 523
Change in total body fat
Time frame
From randomization to Week 524
Change in abdominal visceral fat area
Abdominal visceral fat area is quantified by CT scan
Time frame
From randomization to Week 52Sponsors and contacts
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Source ClinicalTrials.gov