Lipocine has announced results from a Phase II study of LPCN 2401 which has both reduced fat mass and increased muscle mass. Image credit: Halfpoint / Shutterstock

Lipocine hopes its obesity candidate LPCN 2401 could work alongside glucagon-like peptide-1 receptor agonists (GLP1-RAs) to help improve muscle mass in obese patients.

The company announced positive results from its Phase II trial of LPCN 2401, an oral combination of anabolic androgen receptor agonist and α-tocopherol, which both reduced body fat and increased muscle mass.

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Although the changes have been described as ‘modest’, Dr. Mahesh Patel, CEO of Lipocine said that the company believes these could be used alongside GLP-1/GIP agonists to improve muscle mass, quality, and functionality while maintaining weight loss and amplifying fat loss.

Patel added that the company will be meeting with the US Food and Drug Administration (FDA) to discuss the further development of LPCN 2401.

The multi-centre prospective, blinded study enrolled obese or overweight male patients with at least one weight-related comorbidity.

Patients were randomised into three arms and treated for 36 weeks. Arm one received testosterone ester (T ester) as a monotherapy, arm two received T ester and LPCN 2401, and arm three received placebo.

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There were 14 patients who received LPCN 2401 and T ester while 13 patients received a placebo.

LPCN 2401 reduced fat mass by 6.7% versus placebo and increased lean mass by 4.4% at 36 weeks. The candidate also reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8% compared to placebo.

LPCN 2401 was well-tolerated with the frequency and severity of observed adverse events (AEs) comparable to placebo.

Medical director of the Weight Wellness Programme Dr. Jaime Almandoz said that although the reductions in total body weight were modest, LPCN 2401 could result in less negative clinical outcomes compared to many popular interventions for treating obesity which can lead to reductions in lean mass.

Obesity landscape

The obesity landscape is dominated by GLP1RA’s, with both Novo Nordisk and Eli Lilly very much at the helm with their candidates Wegovy and Zepbound.

Lipocine is not the only company looking to enter the obesity world with an alternative mechanism of action, with Japan-based Shionogi & Co investigating an MGAT2, S-309309 while US-based Versanis Biopharmaceuticals is investigating an ACTR2 Antagonist bimagrumab

GlobalData epidemiologists forecast that the total prevalent cases of overweight and obesity combined in the seven major markets (7MM:US, France, Germany, Italy, Spain, UK, and Japan) is expected to increase from 421,970,603 in 2021 to 444,552,780 in 2031.

GlobalData is the parent company of the Clinical Trials Arena.