Pep19: A Novel Approach for Reducing Visceral Fat and Improving Sleep Quality in Obese Adults—Results From an Early-Stage Clinical Trial

Abstract

Background

Conformational-sensitive antibodies were used to identify the orally active peptide DIIADDEPLT (Pep19) as an inverse agonist of cannabinoid type 1 receptor. Pep19 safely improved metabolic parameters in murine models of diet-induced obesity, and in healthy dogs.

Objectives

To evaluate Pep19's impact on quality of life and body composition in obese adults, hypothesising that the metabolic effects of Pep19 observed in animal models could translate to humans.

Methods

Subjects, males (n = 12) and females (n = 12), from 46 to 59 years old, weighing 91–106 kg, body mass index between 30 and 35 kg/m², were evaluated over 60 days in a placebo-controlled, triple-blinded clinical trial; participants received either a placebo, 2 or 5 mg Pep19 capsules once daily at bedtime. The primary endpoint was a broad measure of quality of life assessed using validated questionnaires. The key secondary endpoints included weight loss, reduction in visceral fat (measured by dual-energy X-ray absorptiometry), and changes in waist, hip, and chest measurements.

Results

Pep19 was well tolerated with no reported adverse effects. Remarkable reductions in visceral fat were observed in the 5 mg Pep19 group, with a 17 ± 4.7% loss (p < 0.05), without any change in lean mass. Additionally, sleep quality improved significantly by 35 ± 10% in the 2 mg Pep19 group and 25 ± 16% in the 5 mg Pep19 group (p < 0.05). In the 5 mg Pep19 group, significant reductions in body weight and waist circumferences were also observed (p < 0.05).

Conclusion

Despite the limitations related to the use of convenience sampling, a small sample size, and a short intervention duration, which may restrict generalisation and health claims, Pep19 demonstrates exceptional innovative potential as a novel approach to reduce visceral fat and improve sleep quality.