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Late-Stage Obesity Programs: Variety of Classes Step Up To The Plate

Late-Stage Obesity Programs: Variety of Classes Step Up To The Plate



Results from Phase III studies will help determine the fate of weight management products.

Sponsor & Product

Class & Indication

Phase III Program & Results

Alizyme/Takeda
Cetilistat (ATL962)

Gastrointestinal lipase inhibitor for obesity in patients with comorbidities - diabetes, high blood pressure, high cholesterol

Program will include three 12-month studies; obese diabetics will be studied under separate IND.
Firms have completed special protocol assessments with FDA, but have not yet started trials.

Arena
Lorcaserin (APD-356)

Serotonin receptor agonist for treatment of obesity

Two pivotal studies: BLOOM and BLOSSOM.
BLOOM results released in March 2009. Participants who completed 52 weeks of treatment lost an average of 8.2 percent of body weight and 47.5 percent lost 5 percent or more of their body weight, compared to just 20.3 percent in the placebo arm. Placebo-adjusted weight loss was 3.6 percent. BLOSSOM results expected Q3 2009.

Novo Nordisk
Victoza (liraglutide)

GLP-1 analogue for obesity in non-diabetic patients

Three trials
First study initiated October 2008.

Orexigen
Contrave (360 mg buproprion SR /32 mg naltrexone SR)

Selective norepinephrine reuptake inhibitor and opioid receptor antagonist combination for obesity, including patients with type 2 diabetes

Four studies
First study, NB-302, released in January 2009. Patients lost an average of 20.3 to 25 pounds, or 9.3 percent to 11.5 percent of baseline weight. Placebo adjusted weight loss was 4.2 percent.

Vivus
Qnexa (phenterimine/topiramate)

Appetite suppressant and anti-convulsant combination for obesity, including patients with type 2 diabetes

Three studies: EQUATE, CONQUER and EQUIP
EQUATE reported December 2008. Participants lost 9.2 percent of baseline weight, with 7.5 percent placebo adjusted weight loss.

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