Thursday, March 12, 2015

Beloranib - New Weight Loss Drug Kills 22lbs and Improves Body Fat, Waist Circumference, Blood Lipids, Inflammation and Blood Pressure in 12 Week Study

The novel methionine aminopeptidase 2 (MetAP2) inhibitor, Beloranib, does not (yet?) come in a pill, but it works like the literally "magic" weight loss wonder pill. 40% reduced excess weight in 12 weeks without diet, exercise or surgery - that's without question quite impressive!
Beloranib is an investigational weight loss therapy that is intended to surpass the meager efficacy of previous obesity drugs which achieve an average weight loss of 5% body weight in 12 weeks time in only 30-60% of the patients. medications generally result in 30 to 60% of patients achieving at least 5% weight loss by 12 weeks, and mean placebo-subtracted weight loss of 3 to 9% at one year (2014). Results of which Foster et al. (1997) report that it falls short of patient expectations.

It is thus obvious that there is a need for additional non-surgical weight loss therapies that produce clinically significant weight loss and improvements in cardiometabolic risk factors that are comparable to bariatric surgery but without its risks and limitations.
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With beloranib, a novel methionine aminopeptidase 2 (MetAP2) inhibitior that reduces the biosynthesis of fat and stimulates its release from fat cells and oxidation, the desired obesity drug may be on the horizon.
"Beloranib is a selective and potent MetAP2 inhibitor that significantly reduces food intake, body weight, fat content, and adipocyte size in obese rodent models (Kim. 2007)." (Kim. 2015).
After an investigational 4-week trial in obese women, in whcih intravenous beloranib administration produced weight loss of up to 1 kg per week, as well as improvements in plasma lipids and reductions in hunger (Hughes. 2013), Kim et al. were now the first to conduct a Phase 2 to further investigate the efficacy, safety, and tolerability of a beloranib suspension, administered subcutaneously, for 12 weeks in approximately 150
obese subjects. And their results are stunning.
Figure 1: Effects of different dosages of beloranib on total body weight and excess body weight (Kim. 2015).
In their phase 2 trial, double-blind, randomized study investigated the effects of beloranib suspension (0.6, 1.2, and 2.4 mg) or placebo, administered subcutaneously, for 12 weeks in 147 participants (primarily White females) with obesity. No diet or exercise advice was administered.
Figure 2: Changes in waist circumference, lean mass, body fat, systolic & diastolic blood pressure and hsCRP a reliable marker of whole body inflammation over the course of the 12-week phase 2 trial (Kim. 2015).
Against that background the profound reductions in body fat are impressive, but as you would expect it to happen from pharmacological interventions only (except from roids, obviously), it was not all body fat the subjects lost. The lean mass losses of 2%, 5% and 4% in the 0.6mg, 1.2mg and 2.4mg beloranib groups are yet negligible in view of the profound reductions in inflammation (hsCRP), blood pressure and blood lipids (not shown in Figure 2), the scientists observed.
Table 1: Number of participants reporting adverse events with incidence >10% and greater with any beloranib group vs. placebo (Kim. 2015).
Overall, there is not doubt that this novel methionine aminopeptidase 2 (MetAP2) inhibitior could open a new chapter in the medical treatment of obesity.

In spite of its short term safety (no significant side effects were observed), it remains to be seen, though, whether the drug is also safe if it is taken for another 24 weeks. A timescale that appears to be neccessary to to return the obese and overweight who lost 40% of their superfluous pounds over the course of the 12-week study period (in the high dose group) to a normal body weight.

It is furthermore totally unknown how the drug will affect lean individuals. For them a lean mass loss of 5% may well be significant and the hot flushes which appear to be the only side effect that was absolutely treatment specific (see Table 1) may be a good reason to stick to the tried and proven fat loss strategies which are ... right! Diet & exercise. The two pillars that of successful weight management that were purposefully omitted in the study at hand | Comment on Facebook!
  • Foster, Gary D., et al. "What is a reasonable weight loss? Patients' expectations and evaluations of obesity treatment outcomes." Journal of consulting and clinical psychology 65.1 (1997): 79.
  • Hughes, T. E., et al. "Ascending dose‐controlled trial of beloranib, a novel obesity treatment for safety, tolerability, and weight loss in obese women." Obesity 21.9 (2013): 1782-1788.
  • Kim, Yoo Mee, et al. "Assessment of the anti-obesity effects of the TNP-470 analog, CKD-732." Journal of molecular endocrinology 38.4 (2007): 455-465.
  • Kim et al. "Efficacy and Safety of Beloranib for Weight Loss in Obese Adults: A Randomized Controlled Trial." Diabetes, Obesity and Metabolism (2015): Accepted Article.
  • Yanovski, Susan Z., and Jack A. Yanovski. "Long-term drug treatment for obesity: a systematic and clinical review." JAMA 311.1 (2014): 74-86.