Semaglutide 2.4 mg in Patients With Poor Weight-loss

Korábbi kezelés

• Bariatric surgical procedure other than GB and SG, or revision bariatric surgery of any operation type.
• Personal history of type I diabetes or type II diabetes mellitus currently treated with insulin.
• Concomitant use of GLP-1R agonist or DPPIV-inhibitors.
• History of suicidal attempt in the previous 5 years or untreated severe depression or mental health condition assessed by direct questioning.
• Personal history of acute pancreatitis 180 days before screening or chronic pancreatitis.
• Concomitant usage of medications that cause weight gain or weight loss.
• Known or suspected abuse of alcohol or recreational drugs.

Más betegség

• Symptomatic gallstone disease
• Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
• Known or suspected hypersensitivity to semaglutide or any of the excipients involved in their formulation.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
• Uncontrolled thyroid disease.
• History of stroke, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.
• Untreated clinically significant arrhythmias.
• Severe hepatic impairment diagnosed via liver function blood tests and clinical evaluation

Laborértékek

• Renal impairment measured as glomerular infiltration rate (eGFR <15 ml/min 1.73 m2

Egyéb

• Female who is pregnant, breast-feeding, or intends to become pregnant.
• Current participation in other clinical intervention trial.
• Diabetic gastroparesis.
• Any additional factor, which in the investigator's opinion, might jeopardise the subject's safety or compliance with the trial protocol.

• Patients, ≥1 year primary GB or primary SG, with poor weight-loss (<20% WL) that is not caused by either a surgical or psychological problem.
• Adults, 18-65 years inclusive.
• Females of childbearing potential and female partners of male participants must be willing to use highly effective method of contraception (hormonal or barrier method of birth control; abstinence) (Appendix 2) from the time consent is signed until 2 months after treatment discontinuation.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to randomisation. NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
• A self-reported ≤5 % variation in body weight over preceding 3 months.
• Fluent in English and able to understand and complete questionnaires.
• Participants capable to provide written informed consent and comply with the trial protocol.