Ascending dose-controlled trial of beloranib, a novel obesity treatment for safety, tolerability, and weight loss in obese women

Hughes, T. E., Kim, D. D., Marjason, J., Proietto, J., Whitehead, J. P. and Vath, J. E. (2013) Ascending dose-controlled trial of beloranib, a novel obesity treatment for safety, tolerability, and weight loss in obese women. Obesity, 21 9: 1782-1788. doi:10.1002/oby.20356


Author Hughes, T. E.
Kim, D. D.
Marjason, J.
Proietto, J.
Whitehead, J. P.
Vath, J. E.
Title Ascending dose-controlled trial of beloranib, a novel obesity treatment for safety, tolerability, and weight loss in obese women
Journal name Obesity   Check publisher's open access policy
ISSN 1930-7381
1930-739X
Publication date 2013-09
Sub-type Article (original research)
DOI 10.1002/oby.20356
Open Access Status
Volume 21
Issue 9
Start page 1782
End page 1788
Total pages 7
Place of publication Hoboken United States
Publisher Wiley-Blackwell Publishing
Language eng
Subject 1310 Endocrinology
2701 Medicine (miscellaneous)
2712 Endocrinology, Diabetes and Metabolism
2916 Nutrition and Dietetics
Formatted abstract
Objective:
Evaluate the safety and tolerability of beloranib, a fumagillin-class methionine aminopetidase-2 (MetAP2) inhibitor, in obese women over 4 weeks.

Design and Methods:
Thirty-one obese (mean BMI 38 kg/m 2) women were randomized to intravenous 0.1, 0.3, or 0.9 mg/m 2 beloranib or placebo twice weekly for 4 weeks (N = 7, 6, 9, and 9).

Results:
The most frequent AEs were headache, infusion site injury, nausea, and diarrhea. Nausea and infusion site injury occurred more with beloranib than placebo. The most common reason for discontinuation was loss of venous access. There were no clinically significant abnormal laboratory findings. In subjects completing 4 weeks, median weight loss with 0.9 mg/m2 beloranib was -3.8 kg (95% CI -5.1, -0.9; N = 8) versus -0.6 kg with placebo (-4.5, -0.1; N = 6). Weight change for 0.1 and 0.3 mg/m2 beloranib was similar to placebo. Beloranib (0.9 mg/m2) was associated with a significant 42 and 18% reduction in triglycerides and LDL-cholesterol, as well as improvement in C-reactive protein and reduced sense of hunger. Changes in β-hydroxybutyrate, adiponectin, leptin, and fibroblast growth factor-21 were consistent with the putative mechanism of MetAP2 inhibition. Glucose and blood pressure were unchanged.

Conclusions:
Beloranib treatment was well tolerated and associated with rapid weight loss and improvements in lipids, C-reactive protein, and adiponectin. 
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: Mater Research Institute-UQ (MRI-UQ)
 
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