ENDO 2023 Roundup: More Imcivree Data; Statement on Aging; Novel Hypoparathyroid Tx

CHICAGO — Some of the latest research in the field of endocrinology presented at ENDO 2023, the annual meeting of the Endocrine Society, included studies on testosterone-replacement therapy and the risk of major cardiac events, the incongruence between BMI and body fat percentage, and the glucose benefits of time-restricted eating. Below are a few more highlights.

Treatment for Hypothalamic Obesity Shows Promise

In an extension of a phase II trial including 13 patients with hypothalamic obesity, treatment with setmelanotide (Imcivree) was associated with an average reduction in body mass index (BMI) of 21% after 6 months, reported Christian Roth, MD, of the University of Washington in Seattle, and colleagues.

Most of this weight loss was achieved within the first 16 weeks of treatment, with an average BMI reduction of 16.8%. All participants achieved a BMI reduction of at least 5%, while 10 of the 13 participants were able to achieve at least a 10% reduction.

The most commonly reported adverse events were nausea (69.2%), skin hyperpigmentation (38.5%), and vomiting (30.8%). The most common cause of hypothalamic obesity was treatment of craniopharyngioma, followed by hypothalamic hamartoma, and juvenile pilocytic astrocytoma.

“This impressive response adds to the evidence suggesting setmelanotide may provide a meaningful clinical benefit for patients with this disease who currently have no approved therapeutic options,” said Roth in a statement.

Setmelanotide is currently FDA-approved for certain genetic causes of obesity.

New Scientific Statement on Aging

During the meeting, the Endocrine Society released a scientific statement — also published in the Journal of Clinical Endocrinology & Metabolism — outlining the differences between normal aging and treatable conditions.

Menopause was one of the highlighted conditions in the new statement, as many women experience bothersome symptoms but few actually receive treatment for it. The statement suggested that hormone therapy is safest for women within a 10-year window of the menopause transition or those younger than 60. New non-hormonal hot flash treatments have also shown promise for this population.

“The statement discusses how menopausal symptoms and osteoporosis are often undertreated in the older population, despite evidence that the treatments are both safe and effective,” said lead author Anne Cappola, MD, ScM, of the University of Pennsylvania in Philadelphia, in a statement. “Treating these symptoms and screening for common endocrine conditions that develop or worsen with age could really improve the quality of life for older people.”

Eneboparatide for Chronic Hypoparathyroidism

In a phase II trial, eneboparatide, an investigational long-acting parathyroid hormone 1 receptor agonist, helped patients with chronic hypoparathyroidism achieve independence from conventional therapy.

In the 14-person trial, more than 90% of patients were off active vitamin D and oral calcium therapy after 3 months of eneboparatide treatment, according to Peter Kamenický, MD, PhD, of Le Kremlin-Bicêtre in France, and colleagues.

While nearly half of patients had osteopenia or osteoporosis in at least one site at baseline, bone mineral density scores didn’t significantly change during the trial. On top of that, in the half of patients who had hypercalciuria at baseline, mean 24-hour urinary excretion of calcium dropped by 49%.

No patients in the trial experienced a serious adverse event.

Based on these positive findings, developer Amolyt Pharma said it was initiating a 165-participant phase III trial.