Clinical Trials Roundup: Changing The Path To Clinical Development
Medical Doctor | Medical Writer (Preventive & Metabolic Health)
Dr. Jody-Ann McLean holds an MBBCH (Bachelor of Medicine, Bachelor of Surgery) and has a background in clinical medicine and pathology. Her work focuses on evidence-based health content and the interpretation of medical research.
Trial status and details compiled from ClinicalTrials.gov. Results and topline data drawn from sponsor releases or publications, where applicable. Regulatory information drawn from the FDA. Research accurate as of: 26 September 2026
Several recent developments show a change in the clinical development landscape, from changes in regulatory pathways for moving new drugs into first-in-human trials to a focus on more targeted treatments across kidney disease, metabolic medicine, and oncology. The FDA has launched a pilot that aims to shorten the route between drug identification and clinical testing, while some recent Phase 3 trials compare two weight-management treatments directly against each other, explore new targeted treatments in autoimmune kidney disease, and investigate a first-in-class targeted therapy for pleural mesothelioma. The much-anticipated EASD 2026 annual meeting will also provide further data on emerging metabolic treatments and updated evidence for diabetes management.
FDA Launches Pilot To Speed Up First-In-Human Trials
On the 15th September 2026, the FDA launched its Expedited Investigational New Drug (IND) Pilot. The Expedited IND Pilot is designed to address delays in clinical trial timelines and regulatory processes. This program aims to shorten the time between identification of drug candidates and starting first-in-human clinical trials by looking at whether earlier scientific and regulatory input can improve the quality of IND submissions, identify potential problems earlier on, reduce clinical holds, or make the transition into early clinical development more efficient.
The Pilot will allow drug sponsors to partner with qualified research institutions (for example, academic medical centers or research organizations) that have the relevant scientific expertise needed to assist with the IND application process. By doing this, the FDA may be able to use a rolling review process, where individual components of IND submissions can be reviewed as they are completed rather than waiting for the entire submission before review.
Applications are open until 30 October 2026, and the FDA will likely select 8-10 sponsor-research institution pairs for this initial pilot.
CagriSema Reports Results From Head-to-Head Phase 3 Trial
Novo Nordisk announced topline results on 21st September 2026 for two Phase 3 trials of CagriSema, which is an investigational combination of a long-acting amylin analogue cagrilintide together with the GLP-1 receptor agonist semaglutide (the active ingredient in Wegovy). CagriSema is a once-weekly subcutaneous injection and it is currently being evaluated by Novo Nordisk as a treatment for adults with overweight or obesity (in the REDEFINE trials) and as a treatment for adults with type 2 diabetes mellitus (in the REIMAGINE trials).
The REIMAGINE 5 phase 3 trial compared CagriSema (1.0mg/1.0mg) directly with tirzepatide (5mg) in adults with type 2 diabetes who were not adequately controlled on their current medication of metformin, an SGLT2 inhibitor, or a combination of both. The trial looked at CagriSema’s efficacy in reducing blood sugar as well as body weight. Novo Nordisk reported that CagriSema achieved an estimated mean weight reduction of 12.4% compared with 9.1% for tirzepatide as well as a non-inferior reduction in HbA1c (1.71% for CagriSema versus 1.67% for tirzepatide) at week 60 in this patient cohort. A non-inferior result usually indicates that the experimental treatment works as well or not unacceptably worse than the existing treatment.
Both of the treatments were tested at relatively low doses in REIMAGINE 5, so the results do not offer information on how the two treatments compare at higher or maximum tolerated doses.
Novo Nordisk reported on a second phase 3 trial called REDEFINE 9 which looked at the efficacy of CagriSema versus placebo for weight loss in adults with obesity or overweight. At week 68 of the trial, CagriSema (1.0mg/1.0mg) showed a clinically meaningful estimated weight loss of 21% compared to 2% with placebo.
Novo Nordisk submitted a New Drug Application (NDA) to the FDA last year (December 2025) and is expecting a regulatory decision in the last quarter of this year 2026. REIMAGINE 5 and REDEFINE 9 are two among many trials exploring metabolic medicines that combine more than one biological pathway, offer higher efficacy of weight loss, have different dosing strategies, and can be used in not only obesity but wider applications across related metabolic diseases.
Trial Record: NCT06534411; NCT06388187
New Developments In Kidney Disease Target Disease Progression
FDA-Approval of Finerenone
On 17 September 2026, finerenone (Kerendia) was approved by the FDA for use in adults with chronic kidney disease associated with type 1 diabetes. This is a patient population that has had fewer treatments specifically targeting kidney disease progression. Finerenone was already FDA-approved for chronic kidney disease associated with type 2 diabetes in 2021.
The FDA approval was supported by data from the Phase 3 FINE-ONE trial, which investigated the efficacy and safety of finerenone in people with chronic kidney disease and type 1 diabetes, and found that in comparison to placebo, finerenone (in addition to standard care) demonstrated a significant reduction in urine albumin-to-creatinine ratio (UACR) by 25% at 6 months. UACR is an important marker of heart disease risk and kidney disease progression.
From Supportive Treatment To Mechanism-Specific Therapies: A Focus On Sefaxersen In IgA Nephropathy
IgA nephropathy (IgAN) is a type of chronic autoimmune kidney disease (typically diagnosed in young adults) where deposits of a protein called immunoglobulin A become trapped in the filtering units of the kidney and cause inflammation and scarring. Protein in the urine can be used as a marker of the damage that is caused. Sefaxersen is an experimental medication that targets a part of the complement system (part of the immune system). It inhibits the production of complement factor B in the liver, targeting one of the pathways involved in IgA nephropathy-related kidney damage.
IMAgINATION is a phase 3 trial investigating the efficacy and safety of sefaxersen in people with IgA nephropathy who are at high risk of progressive kidney disease. On the 23rd of September 2026, Roche reported interim results that sefaxersen had shown statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks. The trial will continue to assess kidney function over a period of two years through measurement of glomerular filtration rate (eGFR) at week 105.
The mainstay of therapy for IgA nephropathy has historically been mostly supportive through measures including reducing blood pressure, proteinuria, and lifestyle risk factors, rather than addressing the underlying immune mechanism of the disease. Clinical trials, including IMAgINATION, are now investigating more targeted therapies for higher-risk patients with IgA nephropathy.
Trial record: NCT05901831; NCT05797610
New Phase 3 Trial Tests Targeted Therapy In Pleural Mesothelioma
A new phase 3 trial called sTEADfast was registered on 17 September 2026. The trial, which is sponsored by Vivace Therapeutics, will compare an investigational drug called VT3989 with traditional salvage chemotherapy (either gemcitabine or vinorelbine) in 350 adults with advanced epithelioid pleural mesothelioma who have previously been treated with immunotherapy and chemotherapy. Pleural mesothelioma is a cancer affecting the lining of the lungs, a risk factor being exposure to asbestos. The primary endpoint is listed as overall survival. The estimated start date of the trial is 1st December 2026, with primary completion estimated to be May 2028 and study completion in January 2031.
The sTEADfast trial is notable because it is investigating VT3989, which is a first-in-class TEAD inhibitor. TEAD proteins are transcription factors involved in regulating genes that promote tumor growth and survival, and VT3989 is designed to interfere with this process (by disrupting YAP/TAZ-TEAD transcriptional activity). Data from a phase 1/2 trial supported the move into phase 3, with the FDA granting VT3989 a Fast Track and Orphan Drug Designation (supports development of treatments for rare diseases) for the treatment of mesothelioma.
Trial record: NCT07824986
What To Watch: EASD 2026
The European Association for the Study of Diabetes (EASD) is holding its 62nd Annual Meeting in Milan from 28 September – 2 October 2026. The conference will feature recent developments in diabetes research and progress in diabetes management. Novo Nordisk has indicated they will present additional CagriSema data, and the final 2026 ADA/EASD consensus report on Type 2 diabetes will be presented at the meeting.
Disclaimer: This content is for informational and educational purposes only. It is not intended to provide medical advice or to take the place of such advice or treatment from a personal physician. Consult a qualified healthcare professional regarding specific health questions.