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Набира участници Фаза 1

A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment

Healthy Hepatic Insufficiency

The purpose of this study is to measure how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function and in healthy participants with normal liver function. The safety and tolerability of LY3537031 will also be evaluated. The study drug will be administered subcutaneously (SC) (under the skin).

Начало: 20.10.2025 Край: 01.08.2026 Възраст: 18–85 г. Фундаментална наука

Hungary, New Zealand, Slovakia Eli Lilly and Company NCT07165002

Набира участници Фаза 1

A Study to Evaluate Single and Multiple Doses of TLC-1180 in Healthy Subjects

Healthy Participants

This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-1180 after single- and multiple-ascending doses in healthy subjects.

Начало: 20.10.2025 Край: 01.06.2027 Възраст: 18–55 г. Лечение

New Zealand OrsoBio, Inc NCT07300189

Набира участници Фаза 1

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers

Healthy

This is a Phase 1, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, tolerability, and pharmacokinetics of ZT003 following subcutaneous administration in healthy adult participants. The study includes both single ascending dose (SAD) and multiple ascending dose (MAD) parts.

Начало: 16.10.2025 Край: 10.10.2026 Възраст: 18–65 г. Лечение

Australia Beijing QL Biopharmaceutical Co.,Ltd NCT07184502

Набира участници Фаза 2

A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes

Obesity Overweight Diabetes Mellitus, Type 2

The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.

Начало: 16.10.2025 Край: 01.05.2027 Възраст: 18–75 г. Лечение

Argentina, Australia, Puerto Rico +1 Eli Lilly and Company NCT07215559

Набира участници Фаза 3

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

Metabolic Dysfunction-Associated Steatotic Liver Disease

The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression. Once the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.

Начало: 15.10.2025 Край: 01.08.2032 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +29 Eli Lilly and Company NCT07165028

Набира участници

Wearable Technology and Machine Learning for Early Detection and Risk Assessment of Unacceptable Toxicities in a Paediatric Oncology Cohort

Cancer Infection Digital Health Wearable Devices

Data collection study to establish a predictive model of infection observed during childhood cancer therapy using data captured by wearable technology.

Начало: 15.10.2025 Край: 01.12.2027 Възраст: 5–18 г.

Australia Murdoch Childrens Research Institute NCT07030998

Набира участници

PRIORITY-CONNECT 2 Trial

Colorectal Cancer Colorectal Neoplasms

Objectives: The primary aim of this project is to establish the effectiveness of an individualised stepped, multidisciplinary intervention, including education and peer support group, delivered via a virtual multimodal (p)rehabilitation hub, in reducing postoperative complications within 30-days following colorectal cancer surgery, compared to usual care alone. The secondary aims will be to obtain data on the likely difference in key outcomes including: (i) Quality of life (EORTC QLQ-C30 and QLQ-CR29) (ii) Number of days at home within 30, 90 and 365 days after surgery (DAH-30, 90, 365) (iii) Quality of recovery (QoR-15) (iv) Cost-effectiveness (v) Implementation metrics (RE-AIM) Our hypothesis is that the PRIORITY-CONNECT 2 intervention will be more effective in reducing postoperative complications and more cost-effective than usual care. Study design: Pragmatic Randomised Type I Hybrid Effectiveness-Implementation Trial. Planned sample size: To achieve the primary aim, 564 participants will provide 90% power to detect a 15% difference in 30-day postoperative complication rates between the intervention and control groups. The sample size calculation accounts for up to 10% loss to follow-up, 5% non-compliance and a two-side alpha of 0.05. Selection criteria: A sample of 564 participants undergoing colorectal cancer surgery including open, laparoscopic or robotic-assisted surgery (mostly, anterior resection, sigmoid colectomy, hemicolectomy, total proctocolectomy, subtotal colectomy, total colectomy) at sites throughout Australia will be included. These are common colorectal cancer surgeries performed at the participating centres. All the surgeons involved in this study have clinical appointments in their respective hospitals. Inclusion: Adults aged ≥18 years undergoing elective major surgery for colon or rectal cancer with curative intent; and consulting a colorectal surgeon at least 1 week prior to scheduled surgery. Exclusion: Patients undergoing Pelvic Exenteration (PE), Cytoreductive Surgery (CRS) with or without HIPEC, or concurrent surgery for metastatic disease; or cognitive impairment such that they are unable to provide informed consent. Study Procedure: Participant's treating team will screen and provide an information sheet about the trial to consecutive patients. Interested patients will be contacted by a study researcher to discuss the trial further, answer any questions, confirm eligibility against the inclusion and exclusion criteria, and consent patients. Consenting patients will undergo baseline assessment and be randomised to a virtual multimodal hub (Intervention group) or usual care alone (Control group). The intervention will include the delivery of usual care and evidence-based exercise, nutritional, psychological and nursing interventions, and / or group-delivered peer support. All interventions will be conducted before and after surgery. Duration of the Study: Approximately 60 months. Funding: Medical Research Future Fund (MRFF) 2023 Early and Mid-Career Researchers (Application ID: 2031563). Sponsor: The University of Sydney.

Начало: 15.10.2025 Край: 30.07.2028 Възраст: от 18 г. Поддържаща грижа

Australia Surgical Outcomes Research Centre (SOuRCe) NCT06976710

Набира участници Фаза 1/2

An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)

Progressive Metastatic Castrate Resistant Prostate Cancer

This is a two-part, Phase I/II, open-label, global, multicenter study assessing the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) versus standard of care in participants with progressive metastatic castrate resistant prostate cancer (mCRPC).

Начало: 15.10.2025 Край: 01.12.2030 Възраст: от 18 г. Лечение

Australia, Canada, China +9 Novartis Pharmaceuticals NCT07206056

Набира участници Фаза 1/2

A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer

Small-cell Lung Cancer Neuroendocrine Carcinomas Solid Tumor Show to Express DLL3

This is Phase 1/2, multicenter, clinical study to evaluate the safety, efficacy, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.

Начало: 14.10.2025 Край: 01.05.2029 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +4 IDEAYA Biosciences NCT07174583

Набира участници Фаза 3

A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients

Knee Osteoarthritis

This is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of intra-articular administration of PTP-001 (MOTYS) for the treatment of knee osteoarthritis. The purpose of the trial is to evaluate the efficacy, safety, and tolerability of a single intra-articular injection of PTP-001 compared to placebo over a 52-week period in participants with radiographic and symptomatic knee OA.

Начало: 14.10.2025 Край: 01.10.2027 Възраст: 40–80 г. Лечение

Australia Doron Therapeutics Inc. NCT07219771

Набира участници Фаза 1

A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers

Infectious Diseases Antimicrobial Drug Resistance

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers.

Начало: 10.10.2025 Край: 30.08.2026 Възраст: 18–55 г. Лечение

Australia Bugworks Research Inc. NCT07029932

Набира участници

An Observational Study to Learn More About How Medicines That Block Male Hormones Are Used in People With Prostate Cancer in Australia

Metastatic Hormonesensitive Prostate Cancer (mHSPC)

This is a retrospective, observational study looking at real-world prescription data in Australia. The study focuses on adult men with metastatic hormone-sensitive prostate cancer (mHSPC), a type of prostate cancer that has spread but still responds to hormone therapy. The main goal is to understand the treatment patterns, characteristics, and outcomes for patients who are receiving a class of drugs called Androgen Receptor Pathway Inhibitors (ARPIs), such as darolutamide, enzalutamide, apalutamide, or abiraterone. These drugs are often used in combination with standard Androgen Deprivation Therapy (ADT). The research will use two large, de-identified Australian prescription databases: the Pharmaceutical Benefits Scheme (PBS) and the NostraData retail pharmacy dataset. By analyzing this information, the study aims to describe how these treatments are being used over time, including what proportion of patients receive doublet therapy (ARPI + ADT) or triplet therapy (ARPI + ADT + docetaxel chemotherapy). It will also describe the characteristics of the patients receiving these therapies, such as their age and location. Secondary goals include understanding how well patients adhere to their prescribed ARPI treatment and tracking any changes in medication dosage over time. Since the study uses existing, anonymized data, there is no direct contact with patients and individual patient consent is not required. The findings will provide valuable real-world insights into the use of ARPIs in Australia, which can help inform clinical practice and improve care for men with mHSPC.

Начало: 10.10.2025 Край: 30.11.2026 Възраст: от 18 г.

Australia Bayer NCT07223372

Набира участници Фаза 2

EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

PIK3CA-related Overgrowth Spectrum (PROS)

This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).

Начало: 09.10.2025 Край: 30.09.2030 Възраст: 2–100 г. Лечение

Australia, Belgium, France +5 Novartis Pharmaceuticals NCT06997588

Набира участници

Pelvis Adaptive Radiotherapy (ART)

Pelvis Neoplasms

Pelvis Adaptive radiotherapy (ART) is a two phase study looking at using adaptive radiotherapy to help reduce toxicity for cancer patients having radiotherapy in the pelvic region. Adaptive radiotherapy is a new technology that provides the ability to account for daily changes in anatomy. Adaptive radiotherapy also provides a foundation for which radiotherapy margins might be safely reduced. Phase 1 of this study is looking to see if a radiation therapist centred adaptive workflow can be implemented. If phase 1 of this study is safe and feasible, the study will proceed to phase 2. Phase 2 of the study looks at using adaptive technology to reduce radiation treatment margins. The primary aim of this study is to see whether margin reduced treatment using adaptive radiotherapy can reduce side effects for patients with cancer in the pelvic area.

Начало: 09.10.2025 Край: 30.11.2031 Възраст: от 18 г. Лечение

Australia Royal North Shore Hospital NCT06650033

Набира участници Фаза 1

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.

Healthy Volunteer

The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants.

Начало: 07.10.2025 Край: 15.06.2026 Възраст: 18–65 г. Лечение

Australia Protagonist Therapeutics, Inc. NCT07153146

Набира участници Фаза 1

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.

Начало: 07.10.2025 Край: 30.03.2030 Възраст: от 18 г. Лечение

Australia, Switzerland, United States Amgen NCT07140900

Набира участници Фаза 1

Study of LFD-200 in Healthy Adults and Adults With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

This is a double-blind, randomized, placebo- and active-controlled study investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) doses of LFD-200. The study design includes: a single ascending dose (SAD) study in up to 66 adult healthy participants (HPs) to investigate the effects of a single SC dose, with a 30-day follow-up; a multiple ascending dose (MAD) study in up to 40 HPs to assess up to 4 weekly SC doses, with a 30-day follow-up after the last dose; and a MAD study in up to 70 participants with moderate to severe rheumatoid arthritis (RA) to evaluate up to 13 weekly SC doses, with a 30-day follow-up after the last dose.

Начало: 06.10.2025 Край: 16.07.2027 Възраст: 18–75 г. Лечение

Australia, Georgia, Moldova +2 Lifordi Immunotherapeutics, Inc. NCT07207954

Набира участници Фаза 2

Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion

Ischemic Stroke Tandem Occlusion

Co-STAR is a multicenter, prospective, open-label, Bayesian Optimal Phase 2 (BOP2) trial that aims to assess the safety and efficacy of adjunctive intravenous TBO-309 in Acute Ischaemic Stroke (AIS) patients with tandem occlusion receiving intra-cranial endovascular thrombectomy (EVT) and acute extracranial carotid artery stenting. Co-STARS study will test the hypothesis that patients with tandem occlusion treated with EVT and acute stenting in conjunction with TBO-309 will: * have persistent stent patency without requiring rescue therapy with GPIIb/IIIa inhibitors and * not experience high rates of symptomatic intra-cranial haemorrhage (sICH). Patients with tandem occlusion undergoing EVT and acute stenting will receive intravenous TBO-309 bolus and infusion. TBO-309 is a potent, selective and ATP competitive PI3K\[beta\] inhibitor which reduces platelet activation adhesion/aggregation particularly under conditions of disturbed blood flow and promotes platelet disaggregation. By targeting PI3K\[beta\], TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal hemostasis.

Начало: 04.10.2025 Край: 31.12.2026 Възраст: от 18 г. Лечение

Australia ThromBio Pty. Ltd. NCT06813651

Набира участници Фаза 2/3

A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue

Cachexia Metastatic Pancreatic Ductal Adenocarcinoma

Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.

Начало: 03.10.2025 Край: 10.12.2029 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +8 Pfizer NCT06989437

Набира участници Фаза 2

A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

Multiple Myeloma

The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.

Начало: 03.10.2025 Край: 06.04.2029 Възраст: 18–80 г. Лечение

Australia, Spain, United States Janssen Research & Development, LLC NCT07149857

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