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ENDO 2024 Roundup: Teen GLP-1 Coverage; Novel CAH Drug; Hot Flash Risks

— More research from the Endocrine Society's annual meeting

MedpageToday

BOSTON -- Some of the latest research advancements in hormonal health presented at the Endocrine Society's ENDO 2024 included a daily male birth control gel, semaglutide's taste sensitivity-boosting properties, and a novel drug for congenital adrenal hyperplasia (CAH).

Below are some more scientific highlights from this year's meeting.

Coverage for Teen GLP-1 Users

Insurance coverage of GLP-1 receptor agonists (RAs) for diabetes or weight loss is limited in adolescents, and many of these patients who do start on treatment never actually reach the full recommended doses for their conditions, according to a retrospective review.

Among 599 adolescents (average age 15) prescribed one of these agents from 2019 to 2023, insurance denied 41% of the prescriptions. More denials occurred among pediatric patients without type 2 diabetes (64% vs 32%).

Private insurance denied more prescriptions than Medicaid in patients with type 2 diabetes (54% vs 27%), but the reverse was true for patients without type 2 diabetes (55% private vs 69% Medicaid).

The vast majority of prescriptions (90%) were for liraglutide (Victoza, Saxenda) -- approved in 2019 for type 2 diabetes and in 2020 for obesity in teens -- while the other 10% were for exenatide (Byetta, Bydureon), dulaglutide (Trulicity), or semaglutide (Ozempic, Wegovy).

Of the patients with diabetes on liraglutide, half titrated to 1.8 mg by their first follow-up appointment, around 1 to 3 months after prescription start. A third reached 1.8 mg by 6 months, while 17% never reached this dose indicated for diabetes. In patients prescribed a higher dose of liraglutide, 52% of the teens never reached the 3.0 mg dose indicated for weight loss. Another 42% were able to titrate to this level over 5 weeks as prescribed.

While most had no side effects documented in their charts (82%), those who did most commonly reported gastrointestinal issues (12%) and injection site reactions (2%).

"The lack of insurance approval severely limits GLP-1 RA use in the children who truly need the medications," said lead researcher Gabriel Castano, MD, of Texas Children's Hospital Baylor College of Medicine in Houston, . "This has significant clinical implications since the expected improvements with the use of GLP-1 RA in weight or glucose control are likely dose-dependent. If patients are unable to reach the prescribed dose, they will likely not experience the full beneficial effects of the medication."

Another Investigational CAH Drug

Treatment with atumelnant resulted in rapid and profound reductions in androstenedione for patients with classic CAH, and with no serious side effects, according to initial results from a small open-label phase II .

Six of the 10 participants with available data in the 80-mg dose cohort had androstenedione levels below the upper limit of normal 2 weeks after being treated with atumelnant, and this was sustained through 12 weeks for the four patients with available data at that point. From baseline to 12 weeks, androstenedione reductions reached 96% and 17-hydroxyprogesterone (17-OHP) changes in serum levels were 94% for those four patients.

Patients were treated with the once-daily investigational oral agent, which acts as a novel adrenocorticotropic hormone (ACTH) receptor antagonist. "Atumelnant's unique ability to inhibit ACTH directly at its receptor sets it apart from how we've historically pursued controlling androgen production through supra-physiological doses of glucocorticoids," said TouCAHn investigator Umasuthan Srirangalingam, MBChB, PhD, of the University College London Hospitals NHS Foundation Trust, in a statement.

The most common treatment-emergent adverse events were fatigue, headache, and upper respiratory tract infection.

The TouCAHn study is ongoing and topline results from the complete study are expected in the second half of 2024, said .

Hot Flash Link

Women in midlife with moderate-to-severe vasomotor symptoms have an increased risk for metabolic dysfunction-associated steatotic liver disease (MASLD) compared to those with mild symptom severity, according to a cross-sectional study.

Peri- and post-menopausal women who had moderate-to-severe vasomotor symptoms had higher rates of MASLD versus those with mild symptoms (26.2% vs 12.5%).

When the analysis was restricted to just early postmenopausal women -- up to 5 years after the final menstrual period -- those with moderate-to-severe vasomotor symptoms had an even higher odds of MASLD (24.1% vs 3.6% for those with mild symptoms; adjusted OR 9.33, P=0.045). Models were adjusted for age, physical exercise, alcohol intake, current smoking, history of menstrual irregularity, and hormone replacement therapy use.

MASLD was defined as the having one or more of the following risk factors in a woman with hepatic steatosis:

  • BMI ≥25 or waist circumference ≥85 cm
  • Fasting glucose ≥100 mg/dL or type 2 diabetes or diabetes treatment
  • Blood pressure ≥130/85 mm Hg or antihypertensive treatment
  • Triglycerides ≥150 mg/ dL or related treatment
  • HDL cholesterol ≤40 mg/dL or lipid lowering treatment

"Previously, vasomotor symptoms were primarily seen as indicators of estrogen deficiency, but this study suggests broader implications for cardiovascular health related to this hormonal imbalance," lead investigator Eleni Armeni, MD, MSc, PhD, of the Aretaieio Hospital National and Kapodistrian University of Athens in Greece, . "We hope these findings will encourage healthcare providers to offer comprehensive care to peri- and postmenopausal women, going beyond discussions solely focused on hormone replacement therapy."

  • author['full_name']

    Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.

Disclosures

Castano and Armeni reported no disclosures.

Srirangalingam reported relationships with Diurnal and H Lundbeck.

Primary Source

ENDO 2024

Castano G, et al "Real-world implications and limitations of GLP-1 prescriptions in adolescents" ENDO 2024; SAT-097.

Secondary Source

ENDO 2024

Auchus RJ, et al "Once daily oral atumelnant (CRN04894) induces rapid and profound reductions of androstenedione and 17- hydroxyprogesterone in participants with classical congenital adrenal hyperplasia: initial results from a 12-week, phase 2, open-label study" ENDO 2024; MON-677.

Additional Source

ENDO 2024

Armeni E, et al "The severity of vasomotor symptoms is associated with metabolic dysfunction associated liver disease (Masld) in peri- and postmenopausal women" ENDO 2024; OR25-02.