A new treatment for obesity could be on the way. Research led by the Centre for Obesity Research at University College London has reported that the experimental drug AM833 delivers significant reductions in body weight and waist circumference.
The 26-week, randomised, controlled, phase 2 trial (NCT03856047) examined increasing doses (final dose: 0.3, 0.6, 1.2, 2.4 or 4.5 mg once weekly) of subcutaneous AM833 vs placebo or liraglutide 3.0 mg once daily, along with lifestyle interventions, in adults with obesity (body mass index [BMI], ≥30 kg/m2) or overweight (BMI, ≥27 kg/m2) with related complications, without type 2 diabetes.
At baseline, randomised participants (N=706; female 62%, mean age 52 years) had a mean BMI of 37.8 kg/m2, mean body weight of 107 kg and mean waist circumference of 115 cm.
Body weight decreased progressively and dose-dependently and had not plateaued by week 26, with mean reductions from baseline ranging from 6.0 to 10.8 per cent for AM833 0.3-4.5 mg vs 3.0 per cent with placebo and 9.0 per cent with liraglutide.
Body weight reductions from baseline were greater for AM833 (all doses) vs placebo (estimated treatment differences [ETD]: −3.0 to −7.8%; P<.001) and for AM833 4.5 mg vs liraglutide (ETD: −1.8%; P<.05).
At week 26, 88.7, 53.5 and 18.7 per cent of participants on AM833 4.5 mg achieved ≥5, ≥10 and ≥15 per cent body weight loss, respectively. Waist circumference reductions were greater for AM833 doses 1.2-4.5 mg vs placebo (ETD: −3.4 to −4.8 cm; P<.001).
In general, there were no significant differences in glycaemic and lipid parameters between AM833 and placebo. The most common adverse events with AM833 were gastrointestinal disorders.
All AM833 doses were well tolerated, and no new safety concerns were observed.
The findings suggest that with AM833 for 26 weeks as an adjunct to lifestyle interventions delivers clinically meaningful reductions in body weight and waist circumference, with an acceptable safety and tolerability profile.
References:
Batterham RL, Erichsen L, Francisco A, le Roux CW, McGowan B, Pedersen SD, et al. Efficacy and Safety of AM833 for Weight Loss: A Dose-finding Trial in Adults with Overweight/Obesity. Abstract AD12.03. European Congress on Obesity. 10-13 May 2021.
This article originally appeared on Univadis, part of the Medscape Professional Network.
