Effects of a novel weight‐loss combination product containing orlistat and acarbose on obesity: A randomized, placebo‐controlled trial

Abstract

Objective The aim of this study was to evaluate the effect of a novel, oral, modified‐release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo. Methods The randomized, double‐blind, placebo‐controlled trial had a 26‐week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI ≥30 kg/m2 or ≥28 kg/m2 with risk factors, were randomly assigned to EMP16 120‐mg orlistat/40‐mg acarbose (EMP16‐120/40), EMP16‐150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post‐baseline weight measurement. Results Of 156 randomized participants, 149 constituted the intention‐to‐treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention‐to‐treat population was −4.70% (−6.16% to −3.24%; p < 0.0001) with EMP16‐120/40 and −5.42% (−6.60% to −4.24%; p < 0.0001) with EMP16‐150/50. Conclusions This trial indicates that orlistat and acarbose can be successfully combined in a modified‐release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management.

A Comprehensive Review on Weight Loss Associated with Anti-Diabetic Medications

“…When employing the best dosages, acarbose, as opposed to DPP-4, had an interestingly superior impact on weight loss in such patients [41]. EMP 16 is a brand-new weight-loss combination product that was created as a prospective weight-loss product containing orlistat and acarbose [42]. A six-month, randomized, double-blind, placebo-controlled research study was conducted in 2022, employing 156 obese subjects to examine the impact of this unique combination on weight loss [42].…”

“…EMP 16 is a brand-new weight-loss combination product that was created as a prospective weight-loss product containing orlistat and acarbose [42]. A six-month, randomized, double-blind, placebo-controlled research study was conducted in 2022, employing 156 obese subjects to examine the impact of this unique combination on weight loss [42]. As comparison to the placebo group, the participants who were given EMP 16 demonstrated a 5% greater reduction in body weight [42].…”

“…A six-month, randomized, double-blind, placebo-controlled research study was conducted in 2022, employing 156 obese subjects to examine the impact of this unique combination on weight loss [42]. As comparison to the placebo group, the participants who were given EMP 16 demonstrated a 5% greater reduction in body weight [42]. Longer trials are still required to assess the efficacy and safety of this unique combination, despite the fact that it may be a potential candidate for weight loss [42].…”

Natural products targeting inflammation-related metabolic disorders: A comprehensive review

“…The rising rates of obesity-related illness and death also place a heavy financial burden on healthcare systems [ 153 ]. There are currently available synthetic anti-obesity drugs such as orlistat, a reversible inhibitor of lipase enzymes in the GI tract that can reduce fat absorption [ 102 ], and lorcaserin, a serotonin-2C receptor agonist that suppresses appetite and promotes satiety [ 33 ]. Therefore, numerous natural products have the clinical potential as lipid-lowering agents for obese and overweight people, as shown in Table 6 and Fig.…”

Evaluation of In Vitro Antioxidant, Anti-Obesity, and Anti-Diabetic Activities of Opuntia ficus Cladodes Gel and Its Application as a Preservative Coating for Shrimp during Refrigerated Storage

“…Consequently, inhibiting pancreatic lipase might be a significant way to control obesity. Orlistat, a gastro–pancreatic lipase inhibitory agent, is now licenced for the treatment of long-term obesity, although it produces gastrointestinal adverse effects such as oily spotting, bloating, faecal urgency, faecal incontinence, and steatorrhoea [ 19 ].…”