2025-524612-11-00招募中4 期
Effect of an adjunctive intervention on the tolerability of semaglutide in overweight adults without diabetes: a prospective, randomised, double-blind, single-centre, placebo-controlled clinical trial (SEMTOL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Semaglutide treatment tolerability operationalised as the severity of nausea measured using the 0–10 numeric rating scale (NRS) during the first 96 hours after semaglutide administration.
研究概览
简要总结
To evaluate whether coadministration of adjunctive therpay affects tolerability of semaglutide in overweight non-diabetic patients.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18-70 years
- •Overweight with BMI 30-35 kg/m², or BMI 27-30 kg/m² with at least one overweight-related comorbidity (hypertension, history of cardiovascular disease (e.g., myocardial infarction, stroke, or heart failure), metabolic dysfunction-associated steatotic liver disease, osteoarthritis, sleep apnoea).
- •Has not used semaglutide or other GLP-1 receptor agonist or acamprosate within the last 3 months
- •Has not used antiemetics, laxatives, or GI modulators within last 2 months
- •Is not currently taking medications affecting GI function
- •Is not diagnosed with diabetes or other serious chronic illness
- •Women in fertile age must agree to use effective contraception during the whole study period. Acceptable methods are hormonal contraception, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomised partner, condom/diaphragm/cervical cap and sexual abstinence.
- •Willingness to comply with study procedures
- •Able to provide informed consent
排除标准
- •FSH < 25,8 U/L in women reporting no menstruations ≥1 year
- •Positive urine strip test for pregnancy in women reporting menstruations within last year
- •Baseline health status is not acceptable for outpatient therapy: o eGFR ≤45 mL/min/1.73 m²
- •ASAT and ALAT ≥ 3× ULN (Males ≥150 U/L; Females ≥105 U/L), bilirubin ≥1.5× ULN (≥ 31.5 µmol/L)
- •Known hypersensitivity to semaglutide or its excipients.
- •Currently breastfeeding.
研究组 & 干预措施
SEMAGLUTIDE
Test
干预措施: SEMAGLUTIDE (Drug)
GRANISETRON
Auxiliary
干预措施: GRANISETRON (Drug)
Rice flour
Placebo
干预措施: Rice flour (Drug)
结局指标
主要结局
Semaglutide treatment tolerability operationalised as the severity of nausea measured using the 0–10 numeric rating scale (NRS) during the first 96 hours after semaglutide administration.
Semaglutide treatment tolerability operationalised as the severity of nausea measured using the 0–10 numeric rating scale (NRS) during the first 96 hours after semaglutide administration.
次要结局
- The period mean of the daily well-being according to numerical rating scale compared between treatment groups.
- Patient self-reported usage of daily oral study medication.
- Change in body weight from the baseline
- Change in appetite
- Incidence and severity of other side effects (vomiting, constipation, diarrhoea, abdominal pain, dizziness, fatigue, headache)
研究者
UNIVERSITY OF TARTU
Scientific
University Of Tartu
研究点 (1)
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