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NCT05616052
Comparison of Body Weight Change Through Different Smeglutide Administration Methods
Conditions: Weight Change, Body
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE4
Enrollment: 80
Sponsor: Huashan Hospital
Location: China
Summary
Investigators determined to detect the effect of smeglutide on body weight and metabolic indexes among overweight and obese participants through two different dosing programs.
Eligibility Criteria
Inclusion Criteria:18 ≤ age<75;Overweight or obesity: meet either one of the following standardsPatients with BMI ≥ 24 kg/m2 and at least one obesity complication (hypertension, hyperlipidemia, apnea syndrome, cardiovascular disease)Simple obese patients with BMI ≥ 28kg/m2Abdominal obesity, waist circumference ≥ 90 cm for males and ≥ 80 cm for femalesExclusion Criteria:Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia type 2 (MEN-2) patients.Patients with severe hypersensitivity to smeglutide or any other excipient component.Diabetic patients (glycosylated hemoglobin ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L or blood glucose ≥ 11.1 mmol/L 2 hours after meal or random blood glucose ≥ 11.1 mmol/L).Triglyceride>5.6mmol/L;Participants in other clinical drug trials in recent three months.The range of weight change in recent 90 days is>5kg.Cushing's syndrome and abnormal thyroid function.Pregnant or breastfed women.The study doctor judged that it was not suitable to participate in the test.
Source: ClinicalTrials.gov (NCT05616052). StuddyBuddy aggregates publicly available trial information.