Janssen announced findings of a Phase 2 proof-of-concept clinical trial demonstrating that combination therapy of canagliflozin and phentermine was effective for weight loss in overweight or obese non-diabetic adult patients. Data were presented as a late-breaking poster presentation at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA).
The Phase 2 study was a randomized, multicenter, 26-week trial evaluating the safety and efficacy of canagliflozin in combination with phentermine in 334 adults without type 2 diabetes mellitus (T2DM) and with a body mass index (BMI) of 30 to <50 kg/m2, or 27 to <50 kg/m2 if with hypertension and/or dyslipidemia. Patients either received canagliflozin 300mg with phentermine 15mg, phentermine 15mg monotherapy, canagliflozin 300mg monotherapy, or placebo.
Study findings at 26 weeks showed that combination therapy with canagliflozin and phentermine is associated with a significant placebo-subtracted reduction in systolic blood pressure (–4.2 mmHg; P=0.015) and a statistically significant weight reduction from baseline compared to placebo (7.5% vs. 0.6%; P<0.001). In comparison, treatments with phentermine and canagliflozin alone were associated with 4.1% and 1.9% weight reduction, respectively, from baseline. Additionally, significantly more patients achieved ≥5% weight loss in the canagliflozin with phentermine group vs. placebo (66.7% vs. 17.5%; P<0.001). A tolerable safety profile was observed among patients treated with the combination therapy.
Canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is currently indicated for the treatment of adults with T2DM and is not indicated for the treatment of chronic weight management.Phentermine, a sympathomimetic, is currently indicated as a short-term adjunctive regimen for the management of exogenous obesity in patients with an initial BMI of ≥30kg/m2, or ≥27kg/m2 in the presence of other risk factors (eg, hypertension, diabetes, hyperlipidemia).
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