The Parker Institute participates in a NOVO trial on weight loss medication.

Submitted by Line Rustad on

 

Inclusion criteria

Participants are eligible to be included in the study only if all the following criteria apply:

  1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  2. Male or female (sex at birth).
  3. Age 18 years or above at the time of signing the informed consent.
  4. History of at least one self-reported unsuccessful dietary effort to lose body weight.
  5. Body mass index (BMI) ≥ 27.0 kg/m2 at screening.
  6. Participant must have a desire and be committed to lose at least 25% of their body weight.
  7. Clinical diagnosis of knee osteoarthritis (OA) (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence (KL) grades 2 to 4 as per central reading) in the target kneea. The target knee joint is defined as most symptomatic knee at screening. If pain in knees is equal, the target knee joint will be the dominant leg.
  8. Symptomatic knee OA with first appearance of pain in the target knee > 90 days prior to screening and pain in the target knee for > 15 days over the prior 30 days.
  9. Willingness to complete a 72-hour washout period of analgesics before all visits involving WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) questionnaire (acetaminophen 4 g/day is allowed as rescue medication up until 24 hours before those visits).

aApproximately 15% of randomised participants may have KL grade 4.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

General safety

  1. Known or suspected hypersensitivity to study interventions or related products.
  2. Previous participation in this study. Participation is defined as signed informed consent.
  3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method, as defined in Appendix 4 (Section 10.4).
  4. Participation (i.e. randomisation) in any interventional, clinical study of an approved or non-approved investigational medicinal product within 90 days before screening.
  5. Exposure to an investigational medicinal product within 28 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
  6. Any condition, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
  7. Presence or historya of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in situ carcinomas of the cervix, or carcinoma in situ/high grade prostatic intraepithelial neoplasia) within 5 years before screening.
  8. Surgery scheduled for the duration of the study, except for minor surgical procedures, in the opinion of the investigator.
  9. Known or suspected abuse of alcohol or recreational drugs.
  10. Use of any medication with unknown or unspecified content within 90 days before screening.
  11. Other participant(s) from the same household participating in any NNC0487-0111 study.
  12. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinomaa.
  13. History of chronic pancreatitisa.
  14. Acute pancreatitis within 180 days before screeninga.
  15. Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
  16. History of type 1 or type 2 diabetes mellitusa.
  17. Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes mellitus or pre-diabetes within 90 days before screening.
  18. Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1-based treatment), or amylin analogues within 1 year before screening.
  19. Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 15 mL/min/1.73 m2 (2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (by creatinine)), at screening.
  20. History of organ transplantation (corneal transplants (keratoplasty) allowed) or awaiting an organ transplant.

Weight-related

  1. A self-reported change in body weight > 5% within 90 days before screening irrespective of medical records.
  2. Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.
  3. Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed:
  • Liposuction and/or abdominoplasty, if performed > 1 year before screening.
  • Adjustable gastric banding, if the band has been removed > 1 year before screening.
  • Intragastric balloon, if the balloon has been removed > 1 year before screening.
  • Duodenal-jejunal bypass liner (e.g. Endobarrier), if the sleeve has been removed > 1 year before screening.
  1. Uncontrolled thyroid disease as per investigator’s discretion.

Mental health related

  1. Active or unstable depression or other active or unstable psychiatric conditions, which in the investigator’s opinion can jeopardise participant’s safety or compliance with the protocol.
  2. Any history of suicidal attempta.
  3. Suicidal behaviour within 30 days before screeninga.
  4. Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within 30 days before screening.
  5. A Patient Health Questionnaire 9 (PHQ-9) score of ≥ 15 as assessed at screening.

Please see Section 8.3.1 for C-SSRS definitions of suicidal attempt and suicidal behaviour.

Cardiovascular-related

  1. Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
  2. Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.

Osteoarthritis-related

  1. Any joint prosthesis or joint replacement in target knee.
  2. Arthroscopy or injections into target knee within the last 90 days prior to screening.
  3. Any other joint disease in target knee including gout and pseudogout.
  4. Chronic widespread pain.
  5. Symptomatic hip OA unless treated with hip replacement.
  6. Current use of marijuana or opioids.