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. 

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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).

For more information call (800) 526-7736 or visit Janssen.com.