The field of endocrinology and diabetes management have been the beneficiary of an onslaught of updates and advancements during the past several years and this has continued into 2024, including the month of May. The community received its latest update on the effects of semaglutide in people with type 2 diabetes but also received relevant news for endocrinologists and other healthcare providers managing patients with hypercortisiolism and hypoparathyroidism. In our endocrinology month in review for May 2024, we highlight pipeline news in endocrinology and spotlight our coverage of the landmark FLOW trial from ERA 2024.

Top Endocrinology Headlines

Relacorilant Meets Primary Endpoint in Phase 3 GRACE Trial for Hypercortisolism

On May 28, 2024, Corcept Therapeutics announced the phase 3 GRACE trial had met its primary endpoint, with results suggesting use of the selective cortisol modulator improved loss of blood pressure control among patients with hypercortisolism in the randomized withdrawal phase of the trial.

Results of the withdrawal phase of the trial came less than a month after Corcept announced patients in the open-label phase with Cushing’s syndrome and hyperglycemia, hypertension, or both experienced clinically meaningful and statistically significant improvements in hypertension, hyperglycemia and other key secondary and exploratory endpoints. Based on the data, Corcept Therapeutics expects to submit its application for approval to the US Food and Drug Administration in Q3 2024.

FDA Extends Review for TransCon PTH in Hypoparathyroidism to August 2024

On May 14, 2024, Ascendis Pharma announced the FDA’s decision to extend the review period for their application for palopegteriparatide (TransCon PTH) in the treatment of hypoparathyroidism in adult patients by 3 months to August 14, 2024. According to Ascendis Pharma, the decision is based on the agency’s determination that information submitted in response to the May 2023 CRL constituted a major amendment and comes less than a month after Ascendis Pharma announced the agent had received marketing authorization from the United Kingdom’s Medicines & Healthcare products Regulatory Agency in mid-April.

Nearly 90% of US Adults Meet Cardiovascular-Kidney-Metabolic Syndrome Criteria

A new study from Brigham and Women’s Hospital and Harvard Medical School underlines the prevalence of cardiometabolic risk factors among US adults. An analysis of the , results of the study suggest 90% of US adults meet the criteria for stage 1 or greater cardiovascular-kidney-metabolic syndrome. Specific results demonstrated 10.6% (95% CI, 9.6% to 11.6%) of US adults met criteria for CKM syndrome stage 0, 25.9% (95% CI, 24.6% to 27.1%) for stage 1, 49.0% (95% CI, 47.4% to 50.5%) for stage 2, 5.4% (95% CI, 5.1% to 5.8%) for stage 3, and 9.2% (95% CI, 8.5% to 9.8%) for stage 4 from 2011 through 2020.

These results underline the importance of therapies with potential to address multiple risk factors simultaneously, which further highlight the historic benefits found within the FLOW trial.

FLOW Trial

Captivating endocrinologists, nephrologists, internal medicine spcialists, and cardiologists alike, the FLOW trial promised historic results in topline announcements and delivered on those promises at the 61st Euroiepean Renal Association Congress. Presented at ERA 24, the trial, which compared semaglutide 1.0 mg against placebo therapy in patients with type 2 diabetes and chronic kidney disease, results indicated use of the GLP-1 receptor agonist was associated with historic benefits on a multitude of relevant outcomes, including the trial’s primary and secondary endpoints of interest.

Results of the trial suggested use of semaglutide 1.0 mg was associated with a 24% relative reduction in risk of the trial’s primary composite outcome of major kidney events. In addition to this effect on the primary outcome, the trial also indicated use was associated with benefit favoring semaglutide for each of the confirmatory outcomes, including a slower decline of eGFR (difference, 1.16 ml/min/1.73m2; P <.001), reduced risk of major cardiovascular events (HR, 0.82; 95% CI, 0.68 to 0.98; P = .029), and all-cause mortality (HR, 0.80; 95% CI, 0.67 to 0.95; P = .01).

As part of our coverage of the meeting and results readout, the editorial team of HCPLive Endocrinology detailed the results in an article, an on-site interview with principal investigator Vlado Perkovic, MBBS, PhD, and a pair of expert-led podcasts. Check out all of our associated coverage, including preview clips, below:

Article: FLOW Trial Fortifies Semaglutide's Role in Chronic Kidney Disease and Type 2 Diabetes

Lead Investigator Interview: Vlado Perkovic, MBBS, PhD: Semaglutide's Role in CKD Based on FLOW Results

Diabetes Dialogue: FLOW Trial and Semaglutide's Benefit in Chronic Kidney Disease

Don’t Miss a Beat: Semaglutide and the Future of Kidney Disease, with Brendon Neuen, MBBS, PhD