Start-date window
Every trial is placed on its registered start date, actual or estimated. Select one to jump to its entry.
This edition at a glance
The set runs from an 8,500-participant cardiovascular outcomes trial to a 10-participant gene-editing study. Ten of the fifteen are Phase 3.
Three trials test metabolic agents on endpoints other than body weight: major adverse cardiovascular events, sleep apnea severity and skin lesion counts. Five add a new layer to an established treatment backbone, and five select participants on a molecular or biomarker criterion.
Phase mix
Status at compile time
Trials by therapy area
Oncology
4 trialsTroFuse-055
Sac-TMT plus subcutaneous pembrolizumab around chemoradiation for patients keeping their bladder
Registered title: A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Trial design
Randomized Phase 3. Induction with sac-TMT plus MK-3475A, then chemoradiotherapy with MK-3475A consolidation, compared with chemoradiotherapy alone. Enrolls cT2–T4aN0–N1 MIBC in patients ineligible for radical cystectomy or who opt for bladder preservation. Primary endpoint: event-free survival by blinded independent central review.
Mechanism per registry
“Sac-TMT” (sacituzumab tirumotecan, MK-2870) and “Pembrolizumab and Berahyaluronidase alfa” (MK-3475A), the latter described in the record as subcutaneous pembrolizumab.
Why it matters
Tests whether systemic induction and consolidation added to chemoradiation extend event-free survival in a bladder-sparing pathway. The comparator is chemoradiation alone. Patients who cannot or choose not to undergo cystectomy have few curative-intent alternatives, and the record tracks bladder-intact EFS and cystectomy rate as secondary endpoints.
QLC5508 plus QL2107 against tislelizumab and platinum–etoposide as first-line therapy
Registered title: A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer
Trial design
Randomized, open-label, multicenter Phase 3 in treatment-naïve ES-SCLC (VALG staging), ECOG 0–1. Primary endpoint: overall survival.
Mechanism per registry
“QLC5508” and “QL2107” (exact intervention text). The record excludes patients with prior B7-H3-targeted therapy or prior topoisomerase I inhibitors; it does not otherwise describe either agent.
Why it matters
Tests a two-agent investigational regimen against an immunotherapy-plus-chemotherapy standard, with tislelizumab plus carboplatin or cisplatin and etoposide as the comparator. As registered, the experimental arm is described as QLC5508 in combination with QL2107, and platinum and etoposide are described for the comparator arm. Durable benefit from first-line therapy in ES-SCLC remains limited.
ASKC202 plus limertinib against osimertinib in EGFR-mutant, MET-overexpressing NSCLC
Registered title: ASKC202 Plus Limertinib as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
Trial design
Randomized 2:2:1 Phase 3. Arm A, ASKC202 plus limertinib, and Arm B, osimertinib, are double-blind; Arm C, osimertinib plus pemetrexed and cisplatin or carboplatin, is open-label. First-line non-squamous NSCLC with EGFR exon 19 deletion or L858R and MET protein overexpression by central testing. Primary endpoint: PFS by blinded independent central review.
Mechanism per registry
“ASKC202” plus “Limertinib” (exact intervention text), taken orally per the record’s eligibility criteria. The record excludes prior EGFR inhibitor or c-MET-targeted inhibitor therapy.
Why it matters
Tests whether a combination selected on both EGFR mutation and MET protein overexpression outperforms osimertinib monotherapy in the first-line setting. A concurrent osimertinib–chemotherapy arm adds a second reference point. Eligibility depends on a protein-level MET biomarker read centrally, in addition to EGFR status.
MONITOR
Adding capivasertib when ctDNA shows no molecular response to first-line therapy
Registered title: Adding Capivasertib to Standard Treatment in HR Positive, HER2 Negative Metastatic Breast Cancer Based on ctDNA Testing
Trial design
Phase 3. All participants start a non-steroidal aromatase inhibitor plus a CDK4/6 inhibitor; ctDNA molecular response is assessed after cycle 3 (Guardant Reveal). Participants with baseline-detectable ctDNA who lack molecular response but show no RECIST progression are assigned to continued standard care (Arm 1), NSAI plus CDK4/6 inhibitor plus capivasertib (Arm 2), or fulvestrant plus CDK4/6 inhibitor plus capivasertib (Arm 3). Primary endpoint: PFS in Arms 2 and 3, each compared with historical control.
Mechanism per registry
Capivasertib, described in the record as an investigational targeted drug, added to endocrine therapy and a CDK4/6 inhibitor. The record excludes prior PI3K/AKT inhibitor treatment.
Why it matters
Tests whether a blood-based molecular signal can identify patients for treatment intensification before imaging shows progression. Comparators are historical control, with a continued-standard-care arm alongside. The population is first-line HR-positive/HER2-negative metastatic disease that is not responding at the molecular level after three cycles.
Neurology
2 trialsTARBELA-AD
Oral RO7568282 versus placebo over 72 weeks in amyloid-confirmed early Alzheimer’s disease
Registered title: Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer’s Disease
Trial design
Randomized, double-blind, placebo-controlled, multicenter Phase 2. Mild cognitive impairment or mild dementia due to AD, with AD pathology confirmed by amyloid PET or CSF; ages 50–90. Primary endpoint: change from baseline in CDR-SB at week 72.
Mechanism per registry
“RO7568282” versus placebo, given as an oral capsule (the record requires ability to swallow whole capsules). The record does not state a molecular target.
Why it matters
A 72-week placebo-controlled test of an oral agent on CDR-SB in biomarker-confirmed early AD, with ADAS-Cog-13 and ADCS-ADL as secondary endpoints. Early symptomatic AD remains a setting where slowing clinical decline is the central treatment goal.
TRACE- BRIDGE
Tenecteplase or reteplase before thrombectomy, against thrombectomy alone
Registered title: Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events
Trial design
Multicenter, randomized 1:1:1, open-label Phase 3 with blinded outcome assessment (PROBE). Adults within 4.5 hours of onset with anterior-circulation large vessel occlusion (ICA or MCA M1) and ASPECTS 6–10. Primary endpoint: modified Rankin Scale 0–2 at 90 days. If bridging is superior to direct thrombectomy, reteplase is then tested for non-inferiority to tenecteplase. Sample size may be re-estimated up to 1,800.
Mechanism per registry
Intravenous thrombolysis: “rhTNK-tPA (0.25mg/kg)” or “Reteplase 10 Units (U) plus a second dose of reteplase 10 U”, compared with “No thrombolysis (thrombectomy alone)”.
Why it matters
The record states that the added benefit of intravenous thrombolysis before mechanical thrombectomy has not been conclusively established, and that earlier bridging trials mainly studied alteplase. This trial tests two alternative agents against direct thrombectomy on 90-day functional independence.
Cardiometabolic
3 trialsAMBIENCE
Zenagamtide against placebo on major adverse cardiovascular events
Registered title: A Research Study to Look at How Well Zenagamtide Works Compared to Placebo in People With Established Atherosclerotic Cardiovascular Disease and Either Overweight or Obesity
Trial design
Randomized, placebo-controlled Phase 3 across 769 listed locations. Ages 45 and over with established ASCVD (prior myocardial infarction, symptomatic peripheral artery disease, or prior stroke) and overweight or obesity; type 2 diabetes permitted. Primary endpoint: time to first 4-point MACE (cardiovascular death, non-fatal MI, non-fatal stroke, heart failure hospitalization or urgent heart failure visit).
Mechanism per registry
“Zenagamtide” versus placebo. The record does not state a target; it excludes anyone previously treated with a GLP-1 receptor agonist, GIP receptor agonist or amylin analogue.
Why it matters
An outcomes trial that measures cardiovascular events, not weight. The comparator is placebo. People with established ASCVD and excess weight carry residual event risk, and this primary composite counts heart failure events alongside death, MI and stroke. Secondary endpoints include 3-point and 5-point MACE and eGFR change in participants with baseline eGFR below 60.
VESPER-OSA 2
Once-monthly berobenatide for sleep apnea in people not using PAP
Registered title: A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Trial design
Randomized, double-blind, placebo-controlled Phase 3. Adults with BMI ≥27 kg/m² and moderate to severe OSA who are unable or unwilling to use PAP; any diabetes is excluded. Primary endpoint: change from baseline in apnea-hypopnea index at week 52 by polysomnography.
Mechanism per registry
“Berobenatide” versus placebo, injected under the skin approximately once a month; some doses may be self-administered at home after training.
Why it matters
Tests whether a monthly injectable reduces apnea severity in people who are not using PAP, the standard device therapy. The comparator is placebo. Body weight, hypoxic burden, blood pressure and sleepiness scores are secondary endpoints.
Adjuvanted zoster or RSV vaccination and coronary plaque progression
Registered title: A Study Exploring the Effect of Adjuvanted RZV or RSVPreF3 Vaccines on Coronary Plaque Progression in Adults >=50 Years of Age at Risk for Cardiovascular Events
Trial design
Randomized, observer-blind, placebo-controlled exploratory Phase 2. Adults 50 and over with documented coronary artery calcium and at least two cardiovascular risk factors, no prior ASCVD event, able to undergo serial coronary CT angiography. Primary endpoint: change in total coronary non-calcified plaque volume on CCTA at month 14.
Mechanism per registry
“Adjuvanted RZV vaccine” or “Adjuvanted RSVPreF3 vaccine” versus placebo, given by intramuscular injection per the record.
Why it matters
Evaluates two adjuvanted vaccines on a cardiovascular imaging endpoint rather than an infection endpoint. The comparator is placebo, and the record labels the study exploratory. The population is at-risk adults who have not yet had an atherosclerotic event.
Immunology and respiratory
2 trialsENHANCE-3
Ensifentrine added to inhaled standard of care to prevent COPD exacerbations
Registered title: Ensifentrine (MK-5884) Study for the Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (SOC) (MK-5884-031/RPL554/ENHANCE-3)
Trial design
Randomized, double-blind, placebo-controlled Phase 3. Ages 40–80, on stable LAMA/LABA/ICS or LAMA/LABA for at least two months, at least one moderate or severe exacerbation on that therapy in the prior year, post-bronchodilator FEV1 25% to under 70% predicted, at least 10 pack-years; recent biologic use excluded. Primary endpoint: annualized rate of adjudicated moderate or severe exacerbations over 52 weeks.
Mechanism per registry
“Ensifentrine” (MK-5884) versus placebo, each on top of standard of care.
Why it matters
Measures exacerbation prevention in patients who keep exacerbating despite dual or triple inhaled therapy. The comparator is placebo on the same background. Secondary endpoints include FEV1 AUC0–4h at week 12, SGRQ responder rate at week 24 and severe exacerbation rate.
Olatorepatide, a GLP-1/GIP receptor agonist, in hidradenitis suppurativa with overweight or obesity
Registered title: Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity
Trial design
Randomized, double-blind, placebo-controlled, parallel-group 52-week Phase 2. Moderate to severe HS (at least five inflammatory lesions) in at least two anatomic areas, BMI ≥27 kg/m². Primary endpoint: percent change in total abscess and inflammatory nodule (AN) count at week 52.
Mechanism per registry
Olatorepatide, described in the official title as “a GLP-1/GIP Receptor Agonist”, versus placebo.
Why it matters
Tests a metabolic agonist on inflammatory lesion burden, with weight change, HiSCR50, skin pain, DLQI and hsCRP as secondary endpoints. The comparator is placebo alongside daily topical antiseptics. HS in people living with overweight or obesity is the target population.
Infectious disease
2 trialsCefepime-zidebactam against ceftazidime-avibactam, with or without colistin
Registered title: Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Trial design
Randomized 1:1, double-blind, multicenter Phase 3 across 55 listed locations; 7 to 14 days of treatment. Colistin is added to ceftazidime-avibactam (matching saline in the cefepime-zidebactam arm) when the baseline pathogen is presumed or confirmed resistant to ceftazidime-avibactam. All participants also receive linezolid for at least the first 3 days. Primary endpoints: 14-day all-cause mortality, plus safety and tolerability.
Mechanism per registry
“Cefepime-Zidebactam” versus “Ceftazidime-avibactam with or without Colistin” (exact intervention text).
Why it matters
Uses a mortality endpoint in hospital and ventilator pneumonia, and its design explicitly accommodates pathogens resistant to the active comparator. Gram-negative nosocomial pneumonia with resistant organisms leaves clinicians few options.
CINERGY
Long-acting capsid inhibitor VH4011499 plus cabotegravir as an initial two-drug injectable regimen
Registered title: A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)
Trial design
Randomized, open-label, active-controlled Phase 2b exploring four VH4011499 regimens paired with cabotegravir, against DTG/3TC. Treatment-naïve viremic adults with HIV-1 RNA 1,000–100,000 copies/mL and CD4+ ≥200 cells/µL. Primary endpoint: HIV-1 RNA <50 copies/mL at Month 7 (FDA snapshot).
Mechanism per registry
VH4011499, a “Capsid Inhibitor Long-Acting Injectable” per the brief title, paired with cabotegravir (CAB), an integrase strand transfer inhibitor per the summary.
Why it matters
Tests a fully injectable two-drug starting regimen against an oral two-drug standard, and uses four regimens to explore the therapeutic window for chronic dosing. Injection-site reactions are tracked as secondary endpoints through Month 25.
Rare disease and advanced modalities
2 trialsSTELLAR-2
Salanersen after presymptomatic onasemnogene abeparvovec in infants with SMA
Registered title: A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec
Trial design
Randomized, double-blind, sham-controlled Phase 3. Infants with 5q SMA and two SMN2 copies who received onasemnogene abeparvovec presymptomatically at 42 days of age or younger. Part A (1 year): salanersen 80 mg versus sham, starting about 6 months after gene therapy. Part B (up to 4 years): all participants receive salanersen 80 mg once a year. Primary endpoint: adverse events and serious adverse events in Part A.
Mechanism per registry
Salanersen (BIIB115), given by intrathecal injection via lumbar puncture; the record describes it as helping the SMN2 gene make more SMN protein. Prior therapy, onasemnogene abeparvovec, is described as replacing the missing or abnormal SMN1 gene.
Why it matters
Tests adding an SMN2-directed therapy after gene therapy in the youngest treated patients, against sham. The record notes that gene therapy may not always work as well as expected, which is the unmet need this sequence addresses. Motor milestones, CMAP and neurofilament light chain are secondary endpoints.
Base-edited autologous stem cells to repair the CXCR4 mutation behind WHIM syndrome
Registered title: Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM
Trial design
Non-randomized Phase 1/2, single infusion, 10 participants aged 3 and older (at least 15 kg) with confirmed CXCR4 c.1000C>T, p.R334X. Stem cells are collected by apheresis, base-edited, and returned after conditioning; follow-up runs 5 years, with long-term visits to 15 years. Primary endpoint: safety through 2 years post-infusion.
Mechanism per registry
“Base-edited hematopoietic stem and progenitor cells”: autologous CD34+ cells base-edited to repair CXCR4 mutations, given by infusion. Other listed interventions: busulfan, palifermin, plerixafor, filgrastim.
Why it matters
Tests whether correcting the causal point mutation in a patient’s own stem cells is safe and yields edited blood cells: secondary endpoints include at least 5% gene-edited circulating myeloid cells and more than 200/µL edited neutrophils at 12 months. The record notes that current drugs help control infections but do not cure WHIM. There is no comparator arm; off-target editing is an exploratory endpoint.
Signal convergence
Patterns visible within these 15 trial records, drawn only from this edition’s set.
Metabolic agents measured on something other than weight
Three trials test metabolic agents on non-weight primary endpoints: AMBIENCE on 4-point MACE, VESPER-OSA 2 on apnea-hypopnea index, and olatorepatide on hidradenitis lesion count. Body weight is a secondary endpoint in the latter two; AMBIENCE’s registered outcomes do not include it.
A new layer on an established backbone
Five trials add to a standard rather than replace it: TroFuse-055 around chemoradiation, ENHANCE-3 on inhaled therapy, STELLAR-2 after gene therapy, TRACE- BRIDGE before thrombectomy, and MONITOR on endocrine therapy with a CDK4/6 inhibitor.
Eligibility set by a molecular or biomarker read
Five trials select participants on a defined marker: ctDNA molecular response in MONITOR, central MET protein overexpression plus EGFR mutation in the ASKC202 trial, two SMN2 copies in STELLAR-2, CXCR4 c.1000C>T in the WHIM study, and amyloid PET or CSF confirmation in TARBELA-AD.
Active comparators, not placebo
Four trials randomize against an active regimen: tislelizumab with platinum–etoposide (Qilu), osimertinib (Aosaikang), ceftazidime-avibactam with or without colistin (Wockhardt), and DTG/3TC (CINERGY).
Dosing interval as a design choice
Four trials build the schedule into the question: berobenatide about once a month (VESPER-OSA 2), salanersen once a year (STELLAR-2), a long-acting injectable capsid inhibitor (CINERGY), and subcutaneous pembrolizumab (TroFuse-055).
Follow every edition of Trial Watch
Study starts and signals interpreted twice monthly, with direct study records.
Source and editorial methodology
Selection window: October 16 to 31, 2026 inclusive. All fifteen study records list a start date inside the window. Three dates are reported actual starts; twelve are estimated dates, not verified patient enrollment. Source snapshots and estimates can change after this edition.
Each study supplies two exact-study links: its ClinicalTrials.gov NCT page and one independently checked, study-specific sponsor page or registry mirror. The Roche and GSK links are sponsor trial pages; the others are identified as mirrors. A mirror reproduces registry records and is not independent clinical validation. No general company homepage or generic pipeline is used as a study source.
Sponsor names, phases, planned enrollments, intervention descriptions, trial endpoints, study identifiers and status were reconciled with available registry-derived study pages and sponsor pages on November 3, 2026. The official ClinicalTrials.gov interface could not be independently exported from the text-only browser. Clinical study registration does not constitute evidence of clinical efficacy or safety.
Historical exact-identifier comparison found no collisions with the available Edition 11 to 19 HTML archives. Earlier public Edition 1 to 10 articles were reviewed for named study repetition, but not all early articles publish their full NCT lists. The edition retains globally relevant trials irrespective of country when exact study provenance is available.