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Clinical Trial News

Wegovy Demonstrates Greater Weight Loss in Women with Heart Failure, Study Finds

  • A recent study found that Wegovy (semaglutide) led to more significant weight loss in women compared to men with heart failure with preserved ejection fraction (HFpEF).
  • Women in the trial experienced an average weight loss of 9.6%, while men experienced a weight loss of 7.2% after 52 weeks on a 2.4mg dose of semaglutide.
  • Despite the difference in weight loss, both sexes showed similar improvements in HFpEF symptoms, physical limitations, and exercise function.
  • The research highlights the need for further investigation into the reasons for the discrepancy in weight loss between sexes and its impact on heart failure outcomes.

Sen-Jam Pharmaceutical Completes Enrollment for Phase 2 Upper Respiratory Infection COVID Therapeutic

Sen-Jam Pharmaceutical has successfully completed participant enrollment for the Phase 2 clinical trial of its therapeutic, SJP-002C, aimed at treating Upper Respiratory Infections (URIs) and COVID. The trial, conducted in partnership with Duke University, achieved full enrollment of 150 participants, with no serious side effects reported. SJP-002C is a multi-targeted anti-inflammatory with antiviral capabilities, offering a potential affordable treatment option. The company plans to seek FDA approval for Phase 3 trials and is exploring partnerships for further development and commercialization.

EMA Initiates Review of Roche's Elevidys for Duchenne Muscular Dystrophy

  • The EMA has begun reviewing Roche's Elevidys, a gene therapy for Duchenne muscular dystrophy (DMD), potentially the first DMD gene therapy in Europe.
  • The application is based on Phase 3 EMBARK trial data, which showed clinically meaningful benefits in key secondary functional endpoints.
  • Elevidys is already approved in the US and several other countries for ambulatory patients with DMD, targeting the underlying genetic cause.
  • Roche is also conducting studies like ENVOL and ENVISION to broaden Elevidys' label to include younger and older DMD patients.

Recursion Pharmaceuticals Announces Seven Clinical Readouts Expected Within 18 Months

  • Recursion Pharmaceuticals anticipates seven clinical trial readouts within approximately 18 months, spanning multiple therapeutic areas and clinical phases.
  • Key readouts include Phase 2 data for REC-994 in Cerebral Cavernous Malformation and REC-2282 in Neurofibromatosis Type 2, expected in September and Q4 2024, respectively.
  • Recursion's partnership with Bayer expands with Bayer becoming the first beta-user of Recursion’s LOWE software for drug discovery.
  • The company is advancing internal and partnered programs, leveraging AI/ML solutions and multimodal data to enhance drug discovery and development.

Semaglutide Reduces Kidney Disease Risk by 24% in Landmark FLOW Trial for Type 2 Diabetes Patients

  • The FLOW trial, the first dedicated kidney outcomes study with a GLP-1 receptor agonist, demonstrated that semaglutide significantly reduces major kidney disease events by 24% in patients with type 2 diabetes and chronic kidney disease.
  • The international trial enrolled 3,533 participants over a median follow-up of 3.4 years, comparing weekly semaglutide injections (1.0 mg) against placebo as an adjunct to standard care.
  • Secondary endpoints showed semaglutide reduced major cardiovascular events by 18% and all-cause mortality by 20%, while slowing kidney function decline with improved eGFR slope.
  • The findings address a critical unmet medical need for high-risk patients, as diabetes affects one in three American adults with chronic kidney disease among the 37 million Americans impacted by kidney disease.

Next-Generation Obesity Drugs Target Muscle Preservation and Enhanced Efficacy Beyond GLP-1 Mechanisms

  • Zealand Pharma's amylin analog petrelintide demonstrated 8.6% weight reduction at 16 weeks in Phase Ib trials, positioning itself as a GLP-1 competitor with better tolerability and preserved lean mass.
  • Altimmune's pemvidutide achieved 15.6% weight loss after 48 weeks in Phase II trials while preserving more muscle mass than traditional diet and exercise approaches.
  • Multiple companies are developing dual and triple hormone combinations targeting GLP-1, glucagon, and GIP pathways to address muscle loss limitations of current obesity treatments.
  • The obesity drug market is expected to exceed $110 billion by 2033, driving unprecedented development of 27 GLP-1 and alternative mechanism drugs presented at recent medical conferences.

INHALE-3 Trial Shows Inhaled Insulin Improves Glycemic Control in Type 1 Diabetes Patients

  • The INHALE-3 randomized trial demonstrated that inhaled insulin (Afrezza) plus degludec insulin significantly improved HbA1c levels compared to usual care in 123 adults with type 1 diabetes over 17 weeks.
  • Among participants with baseline HbA1c ≥7%, 21% of those receiving inhaled insulin achieved the target HbA1c goal of <7%, while no patients in the usual care group reached this target.
  • The study revealed mixed outcomes, with 21% of inhaled insulin users showing HbA1c improvement >0.5%, but 26% experienced worsening >0.5% compared to only 3% in the standard care group.
  • Over half of study participants expressed desire to continue inhaled insulin treatment after trial completion, suggesting potential for improved patient satisfaction and adherence.

INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes

NCT05904743CompletedPhase 4
Mannkind Corporation
Posted 7/7/2023

Keytruda Gains 40th FDA Approval for Advanced Endometrial Cancer Treatment

  • Pembrolizumab (Keytruda) secured its 40th FDA approval, combined with chemotherapy, for treating primary advanced or recurrent endometrial cancer in adults.
  • The approval was based on Phase 3 NRG-GY018 trial data, demonstrating a 70% reduction in disease progression risk with pembrolizumab and chemotherapy.
  • Endometrial cancer is projected to become the third-most prevalent cancer in women by 2040, highlighting the importance of this new treatment option.
  • Keytruda, a PD-1 inhibitor, enhances the anti-tumor immune response and has proven effective across various cancers, solidifying its place on the WHO's essential medicines list.

Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer

NCT03914612Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 8/22/2019

FDA Advisory Panel Unanimously Recommends Approval of Lilly's Alzheimer's Drug Donanemab

Drug Approval
  • An FDA advisory committee voted 11-0 to recommend approval of Eli Lilly's donanemab for early Alzheimer's disease, concluding that benefits outweigh risks despite safety concerns.
  • Clinical studies demonstrated that donanemab significantly reduced amyloid plaque buildup in the brain and plasma phosphorylated tau levels, key biomarkers of Alzheimer's disease.
  • If approved later this year, donanemab would become the second drug on the market to treat Alzheimer's disease, with Lilly expecting blockbuster sales potential.
  • The unanimous recommendation positions donanemab for a market showdown with existing competitor Leqembi following anticipated FDA approval.

InnoCare Advances Dual Regulatory Milestones with Tafasitamab BLA Acceptance and BCL2 Inhibitor ICP-248 Clinical Trial Approval in China

Monoclonal AntibodyDrug Approval
  • China's NMPA has accepted and granted priority review to InnoCare's biologics license application for tafasitamab plus lenalidomide combination therapy for relapsed or refractory diffuse large B-cell lymphoma patients ineligible for stem cell transplant.
  • The company received separate approval to initiate clinical trials of its novel BCL2 inhibitor ICP-248 in combination with azacitidine for acute myeloid leukemia treatment in China.
  • DLBCL represents the most common non-Hodgkin lymphoma type globally, accounting for 45.8% of all NHL cases in China, highlighting significant unmet medical need.
  • These regulatory advances strengthen InnoCare's hemato-oncology pipeline with complementary mechanisms targeting CD19 and BCL2 pathways across different blood cancer indications.

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

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