AMAZE 5 og 6: vigtigste in- og eksklusionskriterier
Inclusion criteria
Participants are eligible to be included in the study only if all the following criteria apply:
- Age 18 years or above at the time of signing the informed consent.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- Body mass index (BMI) ≥ 27.0 kg/m2 at screening.
- Participant must have a desire and be committed to lose at least 25% of their body weight.
- (KL) grades 2 to 3 (AMAZE 6 : 2-4).
- Pain in the target knee > 90 days prior to screening and pain in the target knee for > 15 days over the prior 30 days.
Exclusion criteria
General safety
7. History of pancreatitisa.
8. Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) at screening.
9. History of type 1 or type 2 diabetes mellitusa.
10. Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes mellitus or pre-diabetes within 90 days before screening.
11. Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), within 1 year before screening.
Weight-related
12. A self-reported change in body weight > 5% within 90 days before screening
13. medication prescribed for the indication of obesity within 90 days before screening.
Mental health related
14. Any history of suicidal attempta.or Suicidal behaviour within 30 days before screeninga.
15. Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within 30 days before screening.
16. A Patient Health Questionnaire 9 (PHQ-9) score of ≥ 15 as assessed at screening.
Osteoarthritis-related
17. injections into target knee within the last 90 days prior to screening.
18. Any other joint disease in target knee including gout and pseudogout.
19. Chronic widespread pain.
Hvis du er interesseret i at høre mere eller deltage, er du velkommen til at sende en e-mail til line.rustad@regionh.dk sammen med dit telefonnummer. En projektmedarbejder vil derefter kontakte dig så hurtigt som muligt.