Pooled RCTs find mild sleep restriction lowers TSH in women specifically, with no effect overall and no change in FT4. PICO summary and expert commentary.
Author: Hormone Insight Editorial Team
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Summary: In healthy adult volunteers (Japanese n=20-21, non-Japanese n=20-21), single-dose cilofexor 100 mg or firsocostat 20 mg showed higher plasma exposure in Japanese participants: cilofexor AUCinf 1.24-fold higher, firsocostat AUCinf ~2-fold higher compared to non-Japanese participants, with both drugs well-tolerated in both populations, no dose adjustment required based on prior safety data. PICO Description Population Healthy adult volunteers: Japanese (n=20-21) and non-Japanese (n=20-21). Intervention Single-dose cilofexor 100 mg or firsocostat 20 mg with intensive PK sampling. Comparison PK parameters compared between Japanese and non-Japanese participants. Outcome Higher exposure in Japanese (1.24-2x). Well-tolerated. No dose adjustment needed. Clinical Context NASH drug…
📚 Part of the GLP-1 Receptor Agonists Trial Guide — every landmark trial in one place. Clinical Context Diabetic kidney disease (DKD) remains the leading cause of end-stage renal disease worldwide, affecting approximately 40% of patients with type 2 diabetes. Despite advances in glucose and blood pressure control, many patients progress to kidney failure requiring dialysis or transplantation. Until recently, SGLT2 inhibitors were the only glucose-lowering agents proven to slow DKD progression in dedicated renal outcomes trials. The FLOW trial (Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes) represents a watershed moment in nephrology: the…
A phase 2b randomized trial found that cotadutide reduced urinary albumin-to-creatinine ratio versus placebo in type 2 diabetes with chronic kidney disease, a surrogate signal requiring confirmation. PICO summary and expert commentary.
Design and baseline-cohort paper for the phase 3 ESSENCE trial of semaglutide 2.4 mg in biopsy-proven MASH with fibrosis stage 2 or 3; no efficacy outcomes are reported. PICO summary and expert commentary.
A single-centre randomized trial testing an integrated data platform plus dietary management against routine care in 180 adults with type 2 diabetes. PICO summary and expert commentary.
A post hoc analysis of SUSTAIN 6 reports lower odds of new-onset diabetic kidney disease with semaglutide versus placebo in people with type 2 diabetes. PICO summary and expert commentary.
A post hoc analysis of SUSTAIN China examining whether the glycaemic efficacy of once-weekly semaglutide versus sitagliptin in adults with type 2 diabetes varies by baseline characteristics. PICO summary and expert commentary.
A small single-dose pharmacokinetic study found that combining insulin icodec and semaglutide into IcoSema roughly doubled semaglutide peak concentration without changing total exposure of either drug. PICO summary and expert commentary.
A manufacturer-sponsored 28-week RCT used mixed-meal testing to compare how tirzepatide and semaglutide improve glucose control in type 2 diabetes. PICO summary and expert commentary.