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Clinical Trial News

Hydroxychloroquine Shows Moderate COVID-19 Prevention in Large Clinical Trial

  • A large, double-blind, placebo-controlled trial (COPCOV) found a 15% reduction in symptomatic COVID-19 with hydroxychloroquine compared to placebo.
  • The study also demonstrated a significant reduction in all-cause respiratory illness and fewer workdays lost due to illness among those taking hydroxychloroquine.
  • Hydroxychloroquine was well-tolerated and safe in the study, which included over 4,600 participants across 11 countries from 2020 to 2022.
  • Researchers emphasize that current immunity from vaccines and natural infections has reduced COVID-19 severity, making hydroxychloroquine unnecessary for prevention today.

Survodutide Shows Promise in Obesity and MASH with Significant Weight and Blood Pressure Reduction

• Survodutide, a novel dual GCGR/GLP-1R agonist, demonstrates significant weight reduction in overweight or obese patients, with nearly 40% achieving over 20% body weight reduction after 46 weeks. • Phase II trial results indicate survodutide substantially reduces blood pressure in patients with metabolic dysfunction-associated steatohepatitis (MASH), showing promise in this area. • The dual mechanism of action of survodutide offers benefits in lowering body weight and promoting blood pressure reduction without causing muscle loss, according to study findings. • Adverse events leading to discontinuation were mainly due to rapid dose escalation, suggesting a more gradual approach could mitigate this issue and improve tolerability.

A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

NCT04771273CompletedPhase 2
Boehringer Ingelheim
Posted 4/27/2021

A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

NCT04667377CompletedPhase 2
Boehringer Ingelheim
Posted 3/8/2021

Nivolumab and Nab-Paclitaxel Show Promise in Muscle-Invasive Bladder Cancer

  • A phase II trial (NURE-Combo) evaluated neoadjuvant nivolumab plus nab-paclitaxel followed by adjuvant nivolumab in muscle-invasive bladder cancer patients ineligible for cisplatin.
  • The study met its primary endpoint, with 32.3% of patients achieving a pathologic complete response (ypT0N0) after neoadjuvant treatment and radical cystectomy.
  • The combination demonstrated a manageable safety profile, with grade 3/4 treatment-related adverse events occurring in 25.8% of patients.
  • These findings suggest a potential non-cisplatin-based chemoimmunotherapy approach for muscle-invasive bladder cancer, warranting further investigation.

Ultrasound Elastography Variability Defined for Liver Disease Clinical Trials

  • A recent study published in Radiology identifies variability in ultrasound elastography measurements of liver tissue, crucial for interpreting disease progression in clinical trials.
  • The study, part of the FNIH's NIMBLE project, evaluated SWE and VCTE ultrasound technologies in patients with metabolic dysfunction-associated steatotic liver disease (MASLD).
  • Researchers found that differences of less than 30.7% in SWE and 35.6% in VCTE measurements may reflect technical variability rather than actual changes in liver stiffness.
  • These findings will help clinicians avoid unnecessary changes in patient management and guide future studies validating ultrasound technology for clinical trials.

Rilertinib Demonstrates Superior Survival in EGFR-Mutated NSCLC in Phase 3 Trial

  • Phase 3 trial reveals rilertinib significantly improves overall survival in patients with EGFR-mutated non-small cell lung cancer (NSCLC).
  • The study highlights rilertinib's potential as a novel treatment option for patients who have progressed on prior EGFR tyrosine kinase inhibitors.
  • Rilertinib showcases a manageable safety profile, offering a promising alternative with improved efficacy in advanced NSCLC.
  • These findings support rilertinib's role in addressing the unmet need for effective therapies in EGFR-mutated NSCLC, potentially changing treatment paradigms.

Tremfya (Guselkumab) Approved by FDA for Ulcerative Colitis Treatment

  • The FDA has approved Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis, marking a new treatment option.
  • Tremfya is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64.
  • Clinical trials showed significant improvements in clinical remission and endoscopic remission compared to placebo, supporting the approval.
  • Tremfya is administered intravenously for induction, followed by subcutaneous injections for maintenance, offering flexible dosing regimens.

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

NCT04033445Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 9/26/2019

Ascendis Pharma's Yorvipath Receives Orphan Drug Exclusivity in the U.S. for Hypoparathyroidism

  • Ascendis Pharma's Yorvipath (palopegteriparatide) has been granted Orphan Drug Exclusivity by the U.S. FDA for treating hypoparathyroidism in adults.
  • The exclusivity provides seven years of market protection in the U.S., preventing similar drugs from being marketed for the same indication.
  • Yorvipath is a prodrug of parathyroid hormone (PTH [1-34]) designed for once-daily administration, offering continuous PTH exposure over 24 hours.
  • Hypoparathyroidism, affecting 70,000-90,000 people in the U.S., is a rare endocrine disorder caused by insufficient parathyroid hormone levels.

CIH Therapies Show Promise for Chronic Musculoskeletal Pain in Military Population

  • A recent study investigated the effectiveness of Complementary and Integrative Health (CIH) therapies versus Standard Rehabilitative Care (SRC) for chronic pain in active-duty service members.
  • The SMART design trial randomized participants to CIH or SRC, with options to switch or combine treatments based on initial response, lasting for six weeks.
  • Both groups showed significant pain improvement over six months, with CIH demonstrating earlier benefits, suggesting it as a viable initial approach for chronic pain management.
  • The findings support expanding access to CIH therapies, offering clinicians confidence in recommending them as a starting point based on patient preference.

FDA Clears AI-Powered Brain Mapping Tool for Personalized Neuromodulation Therapies

  • Turing Medical's Bullsai Identify, an AI-driven platform, has received FDA clearance for creating personalized brain maps used in neuromodulation therapies.
  • The platform analyzes advanced MRI data to map individual brain structures, aiming to improve the precision and efficacy of treatments like deep brain stimulation (DBS).
  • Bullsai Identify helps doctors target specific brain regions, potentially reducing side effects and enhancing clinical outcomes for neurological conditions.
  • This clearance marks a step toward accessible precision medicine in neurological care, offering tailored neuromodulation strategies based on individual brain anatomy.

TriClip TEER Shows Sustained Benefits in Tricuspid Regurgitation at 3 Years

  • Transcatheter edge-to-edge repair (TEER) using Abbott's TriClip device significantly reduces tricuspid regurgitation (TR) to moderate or less in 79% of patients.
  • The reduction in TR observed after one year with TriClip was sustained at three years, indicating long-term efficacy of the treatment.
  • Patients treated with TriClip experienced a notable improvement in quality of life, with a decrease in NYHA class III/IV heart failure symptoms from 76% to 19%.
  • The major adverse event rate remained minimal over the three-year follow-up, reinforcing the favorable safety profile of the TriClip TEER procedure.

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