E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029883 |
E.1.2 | Term | Obesity |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To confirm superiority of semaglutide subcutaneous (s.c.; under the skin) 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with obesity and knee osteoarthritis (OA) in change from baseline to week 68 in body weight and knee OA-related pain. |
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E.2.2 | Secondary objectives of the trial |
1) To confirm superiority of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with obesity and knee OA in achieving body weight response criteria after 68 weeks from baseline as well as change from baseline to week 68 in knee OA-related and general physical function. 2) To compare the efficacy of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with obesity and knee OA in change from baseline to week 68 in waist circumference, knee OA-related stiffness, overall knee OA-related physical limitations, general health-related quality of life, and in use of analgesics. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female, age above or equal to 18 years at the time of signing informed consent - Body Mass Index (BMI) greater than or equal to 30.0 kg/m^2 - Clinical diagnosis of knee OA (American College of Rheumatology criteria) with moderate radiographic changes (Kellgren-Lawrence (KL) grades 2 or 3) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees are equal target knee joint will be in the most dominant leg. - Pain due to knee OA |
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E.4 | Principal exclusion criteria |
- Joint replacement in target knee - Arthroscopy or injections into target knee within last 3 months prior to enrolment - Active joint disease besides knee OA |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Change in body weight 2. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1-2: From baseline (week 0) to end of treatment (week 68) |
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E.5.2 | Secondary end point(s) |
1. Achieving body weight reduction ≥5% (yes/no) 2. Achieving body weight reduction ≥10% (yes/no) 3. Change in WOMAC physical function score 4. Change in Short Form 36 (SF-36) physical functioning score 5. Change in waist circumference 6. Change in WOMAC stiffness score 7. Change in WOMAC total score 8. Change in SF-36 bodily pain score 9. Change in SF-36 physical component summary 10. Change in SF-36 mental component summary 11. Use of allowed rescue analgesics used during wash out 12. Amount of allowed rescue analgesics used during wash out 13. Change in pain medication 14. Change in pain intensity (NRS) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-14: From baseline (week 0) to end of treatment (week 68) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Colombia |
Russian Federation |
Saudi Arabia |
South Africa |
United States |
European Union |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 15 |