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Beloranib: New Obesity Drug on the Horizon
Zafgen Inc., the makers of the medication Beloranib, are seeking approval for use with three
conditions: Prader-Willi syndrome, acquired Prader-Willi syndrome (resulting from treatment of
benign tumors in the middle of the brain), and severe obesity complicated by type 2 diabetes.
In clinical trials, beloranib has been shown to burn fat, reduce levels of low density lipoprotein
(LDL) cholesterol, improve liver health, and decrease levels of inflammation in the body
(reduced c-reactive protein levels). The medication works by blocking an enzyme that controls
the release of fatty acids while an increase in metabolism allows the body to burn off excess fat
as fuel simultaneously. The drug also reduces hunger and food intake. Beloranib is able to
reduce the activity of stress markers that lead to changes in fat and cholesterol metabolism,
and to stimulate the body’s inflammation cascades.
Three consecutive phase 1b studies demonstrated rapid weight loss averaging approximately
one kilogram per week.
Positive efficacy and safety data from a completed phase 2 trial of Beloranib in patients with
hypothalamic injury associated obesity was presented at the ENDO 2015 conference. People
with hypothalamic injury associated obesity (HIAO) are unable to regulate metabolism and food
intake normally; they experience rapid and intractable weight gain and treatment-resistant
severe obesity with associate comorbidities as a result. HIAO is most commonly caused by
damage incurred during removal of a central nervous system tumor, but can also result from
strokes, brain trauma, or radiation therapy to the brain. The phase 2 randomized, double-blind,
placebo-controlled trial evaluated the efficacy, safety, and tolerability of beloranib 1.8
milligrams (mg) administered twice-weekly for four weeks followed by an optional four-week,
open label extension. The mean age of participants was 31.9 years, the mean body mass index
(BMI) was 42.9, and the mean body weight was 126.4 kilograms (kg). The participants were not
advised to follow any diet or exercise regimens. After four weeks of treatment, the participants
who had been randomized to beloranib lost on average 3.4 kg of body weight vs 0.25 kg for
individuals given the placebo.
On October 1, 2014, Zafgen announced initiation of a phase 3 trial of Beloranib in Prader-Willi
Syndrome. The “bestPWS” trial is a randomized, double-blind, placebo-controlled trial in obese
adolescents and adults with Prader-Willi Syndrome to evaluate food related behaviors, total
body fat mass, and safety of beloranib. Eighty-four patients at 14 sites across the United States
(US) will be given either a placebo, 1.8 mg or 2.4 mg twice weekly injections during the
randomized treatment period of six months. Prader-Willi syndrome is a rare disease and the
most common known genetic cause of life-threatening obesity resulting from impaired
functioning of the hypothalamus.
Most weight loss medications work by suppressing a person’s appetite by focusing on the
brain’s hypothalamus; unfortunately, suicidality and depression are all co-regulated by the
same part of the brain.
Beloranib is given via injections. Side effects in trials included nausea, vomiting, dizziness,
headache, nasopharyngitis, and sleep disturbance. The drug is a ways off, though, and will likely
not hit the market until 2018 or 2019.
References and recommended readings
Weller C. Medical Daily website. New obesity drug, Beloranib, burns fat without diet and
exercise, ‘targets body, not mind’. Medical Daily website. http://www.medicaldaily.com/newobesity-drug-beloranib-burns-fat-without-diet-and-exercise-targets-body-not-mind-254231.
Published Aug 26, 2013. Accessed April 8, 2015.
Zafgen announces new weight loss and safety data from phase 2 trial of Beloranib in
hypothalamic injury associated obesity at endo 2015. Zafgen website.
http://ir.zafgen.com/releasedetail.cfm?ReleaseID=900435. Published March 7, 2015. Accessed
April 8, 2015.
Zafgen website: http://www.zafgen.com/. Accessed April 8, 2015.
Review Date: 3/16/15
Contributed by Elaine M. Hinzey RDN, LD/N