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Tesomet Gains Orphan Drug Designation for Hypothalamic Obesity

Tesomet is the first and only investigational treatment for hypothalamic obesity to receive orphan drug designation, according to a press release from the manufacturer.

The drug is an investigational fixed-dose combination therapy of tesofensine and metoprolol.

The company is preparing for two Phase 2b studies of the drug later this year, one in HO and the other in Prader-Willi syndrome, for which Tesomet has received orphan drug designation previously.

In a 24-week, double-blind, randomized, placebo-controlled initial Phase 2 trial in HO, adults receiving Tesomet showed statistically significant reductions in body weight and improvements in waist circumference and glycemic control. The improvements were maintained throughout an additional 24-week open-label extension.

Patients well tolerated the drug and adverse events were mild.

The company has initiated multiple partnerships with the HO advocacy community to incorporate caregiver and patient feedback into the clinical trial process and to provide the community with education on clinical trials.


By MD /alert Staff
 

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