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Novel Antiobesity Drug Significantly Improves Body Composition, Bone Mineral Content in Phase 2 Study
LPCN 2401, a combination anabolic androgen receptor agonist and α-tocopherol, decreased fat mass by 6.7% and increased lean mass by 4.4% over 36 weeks, said Lipocine, Inc.
An investigational oral antiobesity agent that combines an anabolic androgen receptor agonist and α-tocopherol was associated with statistically significant improvements in body composition in men with obesity or overweight with at least 1 weight related comorbidity, according to an announcement Thursday from biopharmaceutical company Lipocine.
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In a prospective phase 2 study LPCN 2401 increased lean body mass by 4.4% and decreased fat mass my 6.7% over a period of 36 weeks. In addition, Lipocine reported significant reductions in android fat and increases in bone mineral content. The medication’s tolerability was good and adverse events reported by treated participants were similar to those in the placebo group.
The company suggests that LPCN 2401 has the potential to complement treatment with current incretin-mimetic antiobesity medications, which have been associated with reductions in lean body mass representing up to 40% of total weight loss, according to the press statement. "We are pleased with these results demonstrating that LPCN 2401 improves body composition by gaining lean mass and reducing fat mass," Mahesh Patel, PhD, president and CEO of Lipocine, Inc, said in the announcement. "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.” He adds that LPCN 2401 could help mitigate rebound effects after GLP-1/GIP agonists are discontinued, including “collateral fattening and rebound fat/weight ‘overshoot.’"
For the multicenter, prospective, blinded phase 2 study, researchers enrolled men with obesity (BMI ≥30) and with BMI ≥27 with at least one weight-related comorbidity who were randomly assigned to 1 of 3 treatment groups for 36 weeks: 1, testosterone (T) ester monotherapy capsule; 2, T ester + α-tocopherol capsule (LPCN 2401); or 3, matching placebo. Body composition was measured at study baseline and at weeks 20 and 36 via dual-energy x-ray absorptiometry (DEXA) scans.
Among participants in the LPCN 2401 and placebo groups, 27 were randomly assigned (n = 14 and n = 13, respectively) and completed the baseline and at least 1 additional DEXA scan. The men had a mean age of 52.4 years, and the mean baseline BMI was36.0 kg/m2.
FINDINGS
Compared to those who received placebo, those in the LPCN 2401 group achieved significant loss of fat mass (adjusted difference -6.7; P = .02) and gain of lean mass (4.4; P = .02) with notable improvements recorded as early as week 20, according to Lipocine. There was also a significant reduction in so-called android fat that sits in the area between the pelvis and the ribs (-4.1; P = .04) and significant increase in bone mineral content. Treatment with LPCN 2401 appeared to be weight neutral, according to the Lipocine statement, suggesting loss of fat was offset by gain in lean mass. The substantial decrease in fat to lean mass ratio (-10.6; P = .02) is compelling evidence of overall improvement in body composition, Lipocine said.
"Treatment with LPCN 2401 resulted in loss of fat mass and significant gains in lean mass in men with obesity. Although the reductions in total body weight were modest, this is very exciting as many popular interventions for treating obesity lead to reductions in lean mass, which can result in negative clinical outcomes,” Jaime Almandoz, MD, medical director of the Weight Wellness Program, and an associate professor of internal medicine at UT Southwestern Medical Center, in Dallas, TX, said in the press release.
The adverse health implications associated with loss of lean mass include “weakness/fatigue, lowered metabolism which can cause a regain in fat mass, declines in neuromuscular function, potential effects on emotion and psychological states, and increased risk of injury,” Lipocine noted in the statement.
Lipocine indicated plans to meet with the US Food and Drug Administration to discuss “the further development of LPCN 2401 as an aid to weight management interventions.”
