Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biophytis
Age
18–84
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Willing to participate and able to sign an ICF
BMI ≥30 or BMI ≥27 with one or more weight-associated co-morbidities (e.g. hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease)
Start of treatment with semaglutide for weight loss at Day 3 after the start of the study treatment
Willing to maintain a diet with an average intake of at least 1 gr/kg body weight protein daily
Willing to maintain sufficient exercise, i.e. at least 150 minutes per week moderate-vigorous exercise
Body weight stable (within a 5 kg range) in the 3 months prior to enrolment
Female participants should be at least 12 months post-menopausal) or surgically sterile OR have a negative urine pregnancy test at screening and be willing to use a contraceptive method from screening to 90 days after last dose.
Based on Semaglutide long half-life, participants should consent to use a contraception method 3 months after administration of the last dose intake of semaglutide.
You may not be if
Participant not able to take medications by mouth (as capsules)
Use of disallowed concomitant medications or herbal products: Any herbal products containing 20-hydroxyecdysone and derived from Leuzea carthamoides, Cyanotis vaga, or Cyanotis arachnoidea are not allowed and any other anabolic products, GH/IGF-1 products, spironolactone, metformin, chemotherapeutic agents, antidepressants, and systemic glucocorticoids within three months prior to study enrollment or strong inhibitors of the Organic Anion Transporting Polypeptide (OATP1B3) e.g. rifampicin and cyclosporine. Use of muscle strength-supporting food supplements
Any known hypersensitivity to any of the active substances (20E), and its excipients (the study medication) and the active substance and the excipients of semaglutide.
History or present cholelithiasis or cholecystectomy from medical history or sludge or stones observed on gallbladder ultrasound or any other method.
Presence of contra-indications to semaglutide per current semaglutide Prescribing Information / Summary of Product Characteristics
Current diabetes (both insulin dependent and T2DM)
A history of chronic pancreatitis or acute pancreatitis
Previous surgical obesity treatment or planned obesity surgery during the study period
Use of anti-obesity (weight-loss) medication or use of any GLP-1 RA for diabetes within 90 days before enrollment
BMI \>40
Uncontrolled hypertension (RR above 150/100 mmHg)
NYHA Class III or IV CHF
History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary revascularization within 6 months prior to screening
Clinically significant liver disease, ALT/AST \>5x ULN, or total bilirubin \> 2x ULN, unless the patient has known Gilbert's syndrome
Neuromuscular disorder or CK \>5x ULN
Autoimmune/inflammatory disorders that may cause muscle wasting
Use of antipsychotics, amphetamines, or any other treatments that can affect weight
Clinically significant ECG abnormalities
History of major depressive disorder within the last 2 years
Any lifetime history of suicide attempt
History of any suicidal behavior in the last month
History of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder
Baseline PHQ-9 score ≥15 or any suicidal ideation of level 4 or level 5 on the Columbia-Suicide Severity Rating Scale
History or current gastroparesis (from medical history)
Patients with obesity due to other endocrinologic disorders
eGFR ≤60 mL/min/1.73 m2, based on Cockcroft \& Gault formula OR Participant requiring renal dialysis
Patients with clinically Recognized Eating Disorders
Patients with clinically significant, uncontrolled hyperthyroidism or hypothyroidism, or those with newly diagnosed thyroid disease within the past 3 months.
Clareo Health | Testing the Efficacy, Safety, and PK of 20E in Patients With Obesity Who Are Starting Treatment With the GLP-1 Agonist Semaglutide for Weight Loss.
