Lipocine announces results from phase 2 trial for obesity drug
Betsy Goodfellow | April 12, 2024 | News story | Research and Development | Lipocine, Obesity, clinical trial, weight loss
Lipocine Inc has announced results from its phase 2 clinical trial (NCT04134091), which includes results for LPCN 2401, the company’s oral proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant.
The trial demonstrated significant improvement in body composition through a reduction in fat mass (FM) and an increase in lean mass (LM) or fat free mass (FFM) in patients with a BMI ≥ 30 (obese) or BMI ≥ 27 with at least one weight-related comorbidity, such as hypertension, type 2 diabetes or dyslipidaemia.
Within the multi-centre prospective, blinded phase 2 trial, participants were randomised to receive one of three potential treatments for 36 weeks. These three treatment options were:
- Testosterone ester monotherapy capsule
- T ester and α-tocopherol capsule (LPCN 2401)
- A placebo.
The participants’ body composition was measured using Dual Energy X-Ray Absorptiometry (DEXA) scans at baseline as well as weeks 20 and 36. Safety and tolerability were assessed throughout the trial.
Dr Mahesh Patel, president and chief executive officer of Lipocine, commented: “We are pleased with these results demonstrating that LPCN 2401 improves body composition by gaining LM and reducing FM. As an adjunct therapy to GLP-1/GIP agonists, we believe LPCN 2401 may improve muscle mass, quality, and functionality while maintaining weight loss and amplifying fat loss. Furthermore LPCN 2401 could help to attenuate collateral fattening and rebound fat/weight ‘overshoot’ associated with discontinuation of GLP-1/GIP agonists. We look forward to meeting with the FDA to discuss the further development of LPCN 2401 as an aid to weight management interventions.”
Betsy Goodfellow
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