Semaglutide's Weight Loss Effects in Obesity

Sponsor
Beijing Chao Yang Hospital
Study ID
NCT06825793
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Subcutaneous Injection — DRUG
    All subjects received subcutaneous injections of semaglutide over a 28-week treatment period, which included an initial 16-week dose-escalation phase. The escalation protocol began with a starting dose of 0.25 mg administered once weekly. Every 4 weeks, the dose was gradually increased in a stepwise manner to 0.5 mg, 1.0 mg, 1.7 mg, and finally 2.4 mg, each administered once weekly.

Study Details

This is a non-randomized, concurrent, parallel-controlled clinical trial. The objective of this trial is to determine the relationship between weight loss responsiveness to semaglutide in obese patients and their gut microbiota.

Key Dates

Start date
Feb 20, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: SLR group
    Patients with a weight loss of less than 5% at the end of treatment are defined as semaglutide low responders (SLR).
  • Active Comparator: SHR group
    Patients who experience a weight reduction of ≥15% at the treatment endpoint are defined as high responders to semaglutide (SHR).

Primary Outcome Measure

Body weight [ Time Frame: Weight changes will be measured at the following time points: before treatment, and at weeks 4, 8, 12, 16, 20, 24, and 28 after treatment ]

Central Contacts

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