STEP 9
Trial question
What is the role of semaglutide in patients with obesity and knee osteoarthritis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
82.0% female
18.0% male
N = 407
407 patients (332 female, 75 male).
Inclusion criteria: patients with obesity and knee osteoarthritis with moderate-to-severe pain.
Key exclusion criteria: joint replacement in the target knee; arthroscopy or injections into the target knee in the past 3 months; any other joint disease in the target knee.
Interventions
N=271 semaglutide (initiated at 0.24 mg SC once weekly, titrated to the maintenance dose of 2.4 mg once weekly by week 16, and continued for a total of 68 weeks).
N=136 placebo (matching placebo once weekly for 68 weeks).
Primary outcome
Mean reduction in body weight at week 68
13.7%
3.2%
13.7 %
10.3 %
6.8 %
3.4 %
0.0 %
Semaglutide
Placebo
Significant
increase ▲
NNT = 9
Significantly greater reduction in mean body weight at week 68 (13.7% vs. 3.2%; ARD 10.5, 95% CI 8.6 to 12.3).
Secondary outcomes
Significantly greater reduction in mean Western Ontario and McMaster Universities Osteoarthritis Index pain score at week 68 (41.7 points vs. 27.5 points; AD 14.1 points, 95% CI 8.3 to 20).
Significantly greater improvement in 36-Item Short Form Health Survey physical-function score at week 68 (12 points vs. 6.5 points; AD 5.6 points, 95% CI 3.1 to 8).
Significantly greater reduction in mean Western Ontario and McMaster Universities Osteoarthritis Index physical function score at week 68 (41.5 points vs. 26.7 points; AD 14.9 points, 95% CI 9.3 to 20.4).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with obesity and knee osteoarthritis with moderate-to-severe pain, semaglutide was superior to placebo with respect to mean reduction in body weight at week 68.
Reference
Henning Bliddal, Harold Bays, Sébastien Czernichow et al. Once-Weekly Semaglutide in Persons with Obesity and Knee Osteoarthritis. N Engl J Med. 2024 Oct 31;391(17):1573-1583.
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