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Clinical Trial News

Epitomee Medical's Novel Capsule Receives FDA Clearance for Weight Management

  • Epitomee Medical's ingestible capsule has received FDA clearance as a prescription weight management solution for adults with a BMI of 25-40 kg/m².
  • The drug-free capsule works by creating a feeling of fullness in the stomach, aiding weight loss when combined with diet and exercise.
  • Clinical trials, including the RESET study, demonstrated significant weight loss and a favorable safety profile compared to the placebo group.
  • The device offers a novel approach to weight management, providing a non-injectable, easily administered option for a broader patient population.

Immunotherapy Shows Promise in Prostate Cancer with MMRd Mutation

  • Men with prostate cancer and the MMRd mutation experienced significantly extended progression-free survival with dual immunotherapy.
  • The disease control rate at six months in MMRd tumors was 81%, substantially higher than other mutation types.
  • Median progression-free survival in the MMRd group reached 32.7 months, a notable improvement compared to other groups.
  • These findings suggest that immunotherapy could be a beneficial treatment option for a subset of prostate cancer patients with specific genetic profiles.

Apple Watch Receives FDA Clearance for Sleep Apnea Detection Feature

  • Apple has gained FDA clearance for its new Apple Watch feature designed to detect sleep apnea, marking a significant advancement in consumer health technology.
  • The feature leverages the watch's sensors to monitor sleep patterns and identify potential indicators of sleep apnea, a condition affecting millions.
  • This clearance allows Apple to market the sleep apnea detection feature as a medical device, potentially increasing awareness and early diagnosis of the condition.
  • The new capability is expected to be available through a software update, expanding the Apple Watch's role in personal health monitoring.

FDA Approves Dupilumab for Adolescent CRSwNP and Lebrikizumab for Atopic Dermatitis

• Dupilumab (Dupixent) has gained FDA approval as the first drug for adolescents aged 12-17 with chronic rhinosinusitis with nasal polyps (CRSwNP), addressing a critical unmet need. • Lebrikizumab (EBGLYSS) received FDA approval for treating moderate to severe atopic dermatitis in patients 12 and older, offering a new first-line biologic option. • ACIP recommends that all children and adolescents over 6 months receive at least one updated COVID-19 vaccine booster for the 2024-2025 season, enhancing protection against newer strains. • Research indicates that metabolic profiles could potentially identify infants at higher risk for sudden infant death syndrome (SIDS), opening avenues for targeted interventions.

GLP-1 Agonists Like Ozempic Show Promise in Halting Progression of Diabetes-Linked Liver Disease

• A recent study reveals that GLP-1 agonists, such as Ozempic, can reduce the risk of progression to cirrhosis in patients with diabetes-linked fatty liver disease by 14%. • Semaglutide (Ozempic/Wegovy) demonstrates notable effectiveness in preventing the advancement of metabolic dysfunction-associated steatotic liver disease (MASLD) to cirrhosis. • The protective effects of GLP-1 medications are most pronounced when administered early in the course of MASLD, before the onset of cirrhosis. • GLP-1 agonists' benefits are attributed to their ability to reduce body weight, improve blood sugar control, and decrease inflammation, potentially reversing fatty liver disease.

Apple Watch Receives FDA Clearance for Sleep Apnea Detection

  • Apple Watch Series 9, Series 10, and Ultra 2 have gained FDA clearance for sleep apnea detection using built-in accelerometer technology.
  • The new feature, available with watchOS 11, monitors breathing disturbances during sleep and notifies users of potential moderate to severe sleep apnea.
  • The algorithm was validated in a clinical study, showing that every participant identified by the algorithm had at least mild sleep apnea.
  • The Apple Watch analyzes breathing disturbance data every 30 days, allowing users to share reports with healthcare providers for informed discussions.

Perioperative Durvalumab Plus Chemotherapy Improves Survival in Muscle-Invasive Bladder Cancer

  • Perioperative durvalumab combined with neoadjuvant chemotherapy significantly improved event-free survival (EFS) compared to chemotherapy alone in cisplatin-eligible MIBC patients.
  • The durvalumab regimen also demonstrated a 25% reduction in the risk of death, showing a statistically significant overall survival (OS) benefit.
  • A re-analysis of pathologic complete response (pCR) rates showed nominal statistical significance favoring the durvalumab arm, supporting the perioperative approach.
  • The addition of perioperative durvalumab to neoadjuvant chemotherapy was tolerable, with no new safety signals observed in the NIAGARA trial.

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

NCT03732677Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/16/2018

FDA Approves Lebrikizumab (Ebglyss) for Moderate-to-Severe Atopic Dermatitis in Patients 12 and Older

  • The FDA has approved lebrikizumab (Ebglyss), an interleukin-13 inhibitor, for treating moderate-to-severe atopic dermatitis in patients aged 12 and older.
  • Clinical trials (ADvocate 1, ADvocate 2, and ADhere) demonstrated that lebrikizumab, alone or with topical corticosteroids, significantly improved skin clearance compared to placebo.
  • Lebrikizumab offers a convenient monthly maintenance dose and provides lasting symptom relief for those whose eczema is not well-controlled with topical therapies.
  • Expected to be available in the US soon, lebrikizumab has already been approved in Europe and Japan, with further market approvals anticipated.

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis

NCT04178967CompletedPhase 3
Eli Lilly and Company
Posted 10/29/2019

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

NCT04250337CompletedPhase 3
Eli Lilly and Company
Posted 2/3/2020

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

NCT04146363CompletedPhase 3
Eli Lilly and Company
Posted 9/24/2019

Ipsen Discontinues Cabometyx Combination for Prostate Cancer After Phase III Failure

  • Ipsen will not pursue regulatory submissions for Cabometyx (cabozantinib) combined with Tecentriq (atezolizumab) in metastatic castration-resistant prostate cancer (mCRPC) outside the US and Japan.
  • The decision follows the CONTACT-02 Phase III trial, which failed to achieve statistical significance in overall survival (OS) improvement at 24 months.
  • Despite the setback, Exelixis plans to proceed with a supplemental new drug application to the FDA for the combination therapy in mCRPC in the US.
  • Ipsen remains optimistic about Cabometyx's potential as a monotherapy and in combination with immunotherapy for approved indications.

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

NCT04446117Active, Not RecruitingPhase 3
Exelixis
Posted 6/30/2020

CDSCO Releases Draft Guidelines on Good Clinical Practices for Consultation

  • The Central Drugs Standard Control Organization (CDSCO) has released draft guidelines on good clinical practices (GCP).
  • These guidelines aim to standardize clinical trials and ensure data integrity in pharmaceutical research.
  • The draft is open for consultation, inviting feedback from stakeholders to refine the regulatory framework.
  • The move is expected to enhance the quality and reliability of clinical trial data in the Asia-Pacific region.

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