ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT07517042
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mazdutide — DRUG
    Mazdutide is administered subcutaneously at 3.0 mg once weekly for 52 weeks during the weight maintenance period.
  • Intensive Lifestyle Intervention — BEHAVIORAL
    A structured intensive lifestyle intervention including individualized dietary counseling, physical activity guidance, and behavioral modification support for 52 weeks during the weight maintenance period.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo plus Intensive Lifestyle Intervention
    After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive placebo once weekly plus intensive lifestyle intervention for 52 weeks during the weight maintenance period.
  • Experimental: Mazdutide
    After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive mazdutide 3.0 mg once weekly for 52 weeks during the weight maintenance period.
  • Experimental: Mazdutide Plus Intensive Lifestyle Intervention
    After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive mazdutide 3.0 mg once weekly plus intensive lifestyle intervention for 52 weeks during the weight maintenance period.
  • No Intervention: Standard Health Education (Control)
    After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive standard health education only for 52 weeks during the weight maintenance period.

Primary Outcome Measure

Percentage change of body weight [ Time Frame: From randomization to Week 52 ]

Central Contacts

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