Efficacy and safety of beloranib for weight loss in obese adults: a randomized controlled trial

Kim D.D., Krishnarajah J., Lillioja S., de Looze F., Marjason J., Proietto J., Shakib S., Stuckey B.G.A., Vath J.E. and Hughes T.E. (2015) Efficacy and safety of beloranib for weight loss in obese adults: a randomized controlled trial. Diabetes, Obesity and Metabolism, 17 6: 566-572. doi:10.1111/dom.12457


Author Kim D.D.
Krishnarajah J.
Lillioja S.
de Looze F.
Marjason J.
Proietto J.
Shakib S.
Stuckey B.G.A.
Vath J.E.
Hughes T.E.
Title Efficacy and safety of beloranib for weight loss in obese adults: a randomized controlled trial
Journal name Diabetes, Obesity and Metabolism   Check publisher's open access policy
ISSN 1463-1326
Publication date 2015-06
Year available 2015
Sub-type Article (original research)
DOI 10.1111/dom.12457
Volume 17
Issue 6
Start page 566
End page 572
Total pages 7
Place of publication Oxford, United Kingdom
Publisher Blackwell Publishing Ltd
Collection year 2016
Language eng
Formatted abstract
Aim

To assess the efficacy, safety and tolerability of beloranib treatment for obesity.

Methods


This phase II, 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 women) with obesity. No diet or exercise advice was administered.

Results


At week 12, beloranib resulted in dose-dependent progressive weight loss of −5.5 ± 0.5, −6.9 ± 0.6 and −10.9 ± 1.1 kg for the 0.6, 1.2 and 2.4 mg beloranib doses, respectively, compared with −0.4 ± 0.4 kg with placebo (all p < 0.0001 vs placebo). Weight loss with beloranib was associated with corresponding reductions in waist circumference and body fat mass, as well as improvements in lipids, high-sensitivity C-reactive protein and blood pressure. Sleep disturbance and gastrointestinal adverse events were more common with beloranib than with placebo; these were generally mild to moderate, transient and dose-related, and led to more early study withdrawals in participants in the group with the highest dose of beloranib.

Conclusions

In this 12-week phase II study, beloranib produced clinically and statistically significant weight loss and corresponding improvements in cardiometabolic risk factors. Beloranib appeared safe, and the 0.6 and 1.2 mg doses were generally well tolerated. The 2.4 mg dose was associated with increased sleep latency and mild to moderate gastrointestinal adverse events over the first month of treatment. These findings represent a novel mechanism for producing clinically meaningful weight loss.
Keyword Clinical trial
Drug development
Obesity therapy
Randomized trial
Weight loss therapy
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2016 Collection
School of Medicine Publications
 
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