
Search Clinical Trials
| Sponsor Condition of Interest |
|---|
|
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) a1
Merck Sharp & Dohme LLC
Cervical Cancer
Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer
is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer
has spread to other parts of the body.
Researchers want to learn about giving the study medicine sacituzumab tirumotec1 expand
Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: - About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and - If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment Type: Interventional Start Date: Jan 2026 |
|
Pregnenolone as a Treatment for Cannabis Intoxication
Johns Hopkins University
Cannabis Intoxication
The present study will characterize the ability of pregnenolone to reverse the acute
intoxication and associated symptoms of cannabis. Healthy adults with a history of
cannabis use will be recruited to participate in a placebo-controlled, within-subject
crossover study at Johns Hopkins Behavioral P1 expand
The present study will characterize the ability of pregnenolone to reverse the acute intoxication and associated symptoms of cannabis. Healthy adults with a history of cannabis use will be recruited to participate in a placebo-controlled, within-subject crossover study at Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). By clarifying the ability of pregnenolone to reverse cannabis intoxication symptoms, this study will pave the way for larger clinical studies that provide a foundation for the development of future CB1-receptor NAM medications that could be applied in emergency situations and potentially validate pregnenolone as a treatment for cannabis intoxication. Type: Interventional Start Date: Apr 2026 |
|
Safety and Efficacy of wSp Vaccine in Young Children
Serum Life Science Europe GmbH
Acute Otitis Media (AOM)
The goal of this clinical trial is to evaluate whether the wSp vaccine can prevent
nasopharyngeal colonization by pneumococcal bacteria in healthy young children who have
received routine PCV20 vaccination.
The main questions it aims to answer are:
Does wSp vaccine reduce pneumococcal colonizatio1 expand
The goal of this clinical trial is to evaluate whether the wSp vaccine can prevent nasopharyngeal colonization by pneumococcal bacteria in healthy young children who have received routine PCV20 vaccination. The main questions it aims to answer are: Does wSp vaccine reduce pneumococcal colonization in the nose? Does wSp vaccine safely stimulate the immune system to produce antibodies and protective immune responses? Researchers will compare children receiving two injections of wSp vaccine to those receiving saline placebo to see if wSp vaccine reduces colonization and boosts immunity. Participants will: Receive two injections of either wSp or saline at 7 and 9 months of age. Have blood samples taken at 6 and 12 months to measure immune responses. Have nasal swabs collected at several time points and during infections from 6-24 months. Be monitored for ear infections, respiratory illnesses, and other pneumococcal-related infections. Type: Interventional Start Date: Sep 2025 |
|
Financial Toxicity in Patients With Resected Soft Tissue and Bone Sarcomas
M.D. Anderson Cancer Center
Bone Sarcomas
Financial Toxicity
To learn about the financial stress patients undergoing surgery to treat orthopedic
cancer experience because of the costs of cancer care, and to learn about the effects of
financial stress on participants quality of life. expand
To learn about the financial stress patients undergoing surgery to treat orthopedic cancer experience because of the costs of cancer care, and to learn about the effects of financial stress on participants quality of life. Type: Observational Start Date: Sep 2025 |
|
A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus R1
Montefiore Medical Center
Low Back Pain, Chronic
A research study is being conducted to compare two treatments for long-term low back
pain:
- One uses the iovera° system, which applies cold to certain nerves in the lower back.
- The other is the standard treatment called radiofrequency ablation, which uses heat.
The primary objective is1 expand
A research study is being conducted to compare two treatments for long-term low back pain: - One uses the iovera° system, which applies cold to certain nerves in the lower back. - The other is the standard treatment called radiofrequency ablation, which uses heat. The primary objective is to find out which treatment works better to reduce back pain. Participants in this study will be randomly placed in one of the two treatment groups. The clinical research team will check on participant pain levels and overall health before and after the procedure for about 12 months. The entire study will last about 14 months for each participant. Type: Interventional Start Date: Apr 2026 |
|
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms i1
Genentech, Inc.
Healthy Participants
This two-part study will evaluate the bioequivalence, safety, and tolerability of a
single SC dose of trastuzumab administered via handheld syringe/syringe pump (HHS/SP)
with infusion set (IS) and an on-body delivery system (OBDS). expand
This two-part study will evaluate the bioequivalence, safety, and tolerability of a single SC dose of trastuzumab administered via handheld syringe/syringe pump (HHS/SP) with infusion set (IS) and an on-body delivery system (OBDS). Type: Interventional Start Date: Oct 2025 |
|
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and1
Ipsen
Advanced Solid Tumor
Metastatic Solid Tumor
The purpose of this study is to determine the appropriate dosage, safety and
effectiveness of a new drug, IPN01203, in adults with advanced solid tumours.
Advanced solid tumours are cancers that can occur in various organs or tissues and have
spread from their original site to nearby tissues or ot1 expand
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours. Advanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or other parts of the body. There will be two parts to this study: - Phase Ia: This part (called dose escalation) will find the dose range that shows activity against the tumour and can be tolerated by participants by testing different increasing doses of IPN01203. - Phase Ib: This part (called dose optimisation) will assess the ability of the drug to prevent, slow down, or stop the growth of tumours and how the body processes and responds to the drug when given in "low dose" or "high dose." It will also further explore the safety and tolerability. An additional part (phase II) may be added to the study based on the results of phase Ia and phase Ib. Each part will consist of the following periods: - A screening period (up to 28 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre. - A treatment period where all eligible participants will receive IPN01203. Requires approximately 15 visits for the first 2 months followed by 3 visits every month from month 3 until unacceptable toxicity, disease progression, death, upon participant's withdrawal of consent, investigator decision, or study termination by the sponsor, whichever occurs first. There will also be one visit at the end of treatment (EoT), 30 days after the last administration of the study intervention or prior to the start of new anticancer treatment, whichever is earlier. Additionally, there will be one visit (the safety follow-up visit) 90 days after the last administration of study intervention or prior to the start of new anticancer treatment, whichever is earlier. In both parts of the study, participants will undergo blood sampling, urine collection, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded. Each participant will be in this study until death or withdrawal from the study. IPN01203 will be provided to participants who tolerate it for as long as their disease does not progress. Participants may withdraw consent to participate at any time. Type: Interventional Start Date: Feb 2026 |
|
A Study of Questionnaires in Adolescents and Young Adults With Cancer
Memorial Sloan Kettering Cancer Center
Adolescents and Young Adults With Cancer
The purpose of this study is to evaluate a questionnaire called PRO-AYA: Patient-Reported
Outcomes for Adolescents and Young Adults. expand
The purpose of this study is to evaluate a questionnaire called PRO-AYA: Patient-Reported Outcomes for Adolescents and Young Adults. Type: Observational Start Date: Sep 2025 |
|
BAY3401016; Biomarker Study Alport
Bayer
Alport Syndrome
Alport syndrome (AS) is a rare genetic condition that causes kidney disease, hearing
loss, and eye abnormalities that occur due to changes in specific genes (COL4A3, COL4A4,
and COL4A5). These genes help in producing an important protein called collagen. People
with AS have a high risk of developin1 expand
Alport syndrome (AS) is a rare genetic condition that causes kidney disease, hearing loss, and eye abnormalities that occur due to changes in specific genes (COL4A3, COL4A4, and COL4A5). These genes help in producing an important protein called collagen. People with AS have a high risk of developing chronic kidney disease (CKD), a condition in which there is progressive loss in kidney function over time. The kidneys soon lose their ability to remove waste products from the body properly, resulting in end-stage kidney disease. A common sign of decreasing kidney function is the presence of excess protein in the urine that is not usually found with healthy kidneys. This condition is known as proteinuria. The study drug, BAY 3401016 (a monoclonal antibody), is a type of medicine that blocks a protein called Semaphorin 3A (Sema3A), which is thought to be involved in causing kidney damage in AS. By blocking the action of the Sema3A protein, BAY 3401016 may prevent proteinuria and slow down the loss in kidney function due to AS. The main purpose of this study is to learn more about how well BAY 3401016 works in slowing down the loss in kidney function in adults with a rapidly progressing AS. Type: Interventional Start Date: Nov 2025 |
|
Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients
Theolytics Limited
Ovarian Cancer
A research study evaluating a new oncolytic virus, THEO-260, in patients with advanced
ovarian cancer. The trial will investigate different doses of THEO-260 administered by
the intraperitoneal route to identify a dose that is safe, well tolerated, and exhibits
preliminary evidence of anti tumour a1 expand
A research study evaluating a new oncolytic virus, THEO-260, in patients with advanced ovarian cancer. The trial will investigate different doses of THEO-260 administered by the intraperitoneal route to identify a dose that is safe, well tolerated, and exhibits preliminary evidence of anti tumour activity. Type: Interventional Start Date: Feb 2026 |
|
An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123)1
Novartis Pharmaceuticals
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). expand
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). Type: Interventional Start Date: Oct 2025 |
|
Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small1
Boehringer Ingelheim
Non-small Cell Lung Cancer
This study is open to adults 18 years and older who have early-stage non-small cell lung
cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes
provide the instructions for making proteins, and this change leads to a faulty HER2
protein. People can join if their lung1 expand
This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung cancer was removed by surgery, and they have already received certain other anti-cancer treatments. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer without their cancer coming back after surgery, when compared to standard treatment. Zongertinib is being developed to target the faulty HER2 protein, which can cause cancer cells to grow. In this study, participants are assigned by chance to one of two treatment groups, with an equal chance of being in either group. One group takes the study medicine, zongertinib, by mouth once a day for up to 3 years. The other group receives a standard treatment, chosen by their doctor. This standard treatment may be an immunotherapy medicine given by infusion into a vein every 3 or 4 weeks for up to 1 year, or regular check-ups without active study medicine (observation). Participants can be in this study for up to about 11 years. During this time, they visit the study site regularly for check-ups and study-related tests. The frequency of these visits varies depending on their treatment and how long they have been in the study. In addition to visits at the study site, participants in some treatment groups will also have phone calls with the study team every 3 weeks to check on their health between their scheduled visits. Doctors check for any signs of cancer coming back using imaging scans (like CT or MRI scans); these scans are generally done every 3 months for the first 2 years, then every 6 months for the next 3 years, and then yearly. Participants also fill in questionnaires about their overall wellbeing, health and symptoms. Throughout the study, doctors also check participants' health and note any unwanted effects. Type: Interventional Start Date: Jan 2026 |
|
A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma1
Bristol-Myers Squibb
Renal Cell Carcinoma
This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell
Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if
BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC. expand
This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC. Type: Interventional Start Date: Jan 2026 |
|
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
GT Medical Technologies, Inc.
Glioblastoma
This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The
overview of this study is as follows:
- A Screening/Baseline Period of 21 days. During this time, patients will be
randomized into a 1:2 allocation of Arm A:Arm B.
- A Perioperative/Operative Phas1 expand
This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The overview of this study is as follows: - A Screening/Baseline Period of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B. - A Perioperative/Operative Phase where patients will undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B). - An EBRT Prior to Start Period. This occurs within 10 business days prior to EBRT and Concurrent TMZ Phase. - An EBRT and Concurrent TMZ Phase, which will begin 30 ±10 days post-surgery. EBRT (30 fractions) and TMZ will be administered up to 5 days a week for 6 weeks in Arm A, and EBRT (20 fractions) and TMZ will be administered for up to 5 days a week for 4 weeks in Arm B. TMZ will be administered at a dose of 75 mg/m2/day orally for each Arm. - An Adjuvant TMZ Phase, which begins 28 ±7 days following the EBRT and Concurrent TMZ Phase, and is comprised of six 28-day cycles. TMZ (150-200 mg/m2/day orally) will be administered for the first 5 days of each 28-day cycle for each Arm. Tumor treating fields are allowed but are not mandated during this phase. Up to 6 additional cycles (for a total of 12) can be completed at the discretion of the Investigator. - An Early Discontinuation/Follow-Up Phase will occur 28 ±7 days after completion of Cycle 6 of the Adjuvant TMZ Phase, regardless of the total number of cycles completed or any delays in cycle start. If fewer than six cycles are completed, the first follow-up assessment will occur 28 ±7 days after the last administered dose of adjuvant TMZ. If patient has a qualifying event requiring entrance to Early Discontinuation Phase, the first follow-up assessment will occur as soon as feasible, but within 28 days. For any unscheduled visits, data collected should be documented in the case report form (CRF) and must include, but are not limited to, safety evaluations, survival status, and disease status. Type: Interventional Start Date: Dec 2025 |
|
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
Boston Scientific Corporation
Chronic Pain
Intractable Pain
Low Back Pain
Chronic Low-back Pain
Chronic Leg Pain
Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with
chronic pain using commercially approved Boston Scientific SCS Systems per local
Instructions for use (IFU).
In addition, to compile real-world clinical outcomes in subjects with chronic,
intractable low back and/1 expand
Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU). In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain. Type: Interventional Start Date: Nov 2025 |
|
Goal-oriented Telehealth Rehabilitation of Executive Functioning for Veterans With Chronic TBI
VA Office of Research and Development
Mild to Moderate Traumatic Brain Injury
Cognitive Rehabilitation
Veteran
Provision of interventions that address cognitive and emotional problems faced by
Veterans with history of TBI pursuing community reintegration is an important concern for
VA. Using telerehabilitation, the current project will help determine whether
goal-directed training of attentional control fun1 expand
Provision of interventions that address cognitive and emotional problems faced by Veterans with history of TBI pursuing community reintegration is an important concern for VA. Using telerehabilitation, the current project will help determine whether goal-directed training of attentional control functions via personally relevant activities will improve community integration for Veterans with history of TBI and cognitive difficulties. Findings may guide rehabilitation training towards providing services to maximize success in attaining complex functional goals in which Veterans can engage in skill strengthening 'where they are' (any location). Type: Interventional Start Date: Apr 2026 |
|
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. D1
Novartis Pharmaceuticals
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two
different treatment combinations of tulmimetostat in participants with de novo or
recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). expand
The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). Type: Interventional Start Date: Jan 2026 |
|
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants1
Sanofi
Chronic Obstructive Pulmonary Disease
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety,
and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in
adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic
obstructive pulmonary disease (COP1 expand
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: - Screening period of up to 4 weeks - Randomized intervention period of approximately 48 weeks - Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks. Type: Interventional Start Date: Sep 2025 |
|
A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Throu1
Bayer
Left Ventricular Systolic Dysfunction
Heart Failure (Pediatric)
Researchers are looking for a better way to treat children who have heart failure with
left ventricular systolic dysfunction (LVSD). Heart failure is a serious condition where
the heart is unable to pump enough blood to meet the body's needs. This can lead to
symptoms like shortness of breath, fati1 expand
Researchers are looking for a better way to treat children who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure is a serious condition where the heart is unable to pump enough blood to meet the body's needs. This can lead to symptoms like shortness of breath, fatigue, and poor growth in children. The study treatment, finerenone (also called BAY94-8862), works by blocking a protein involved in inflammation, scarring, and thickening of the heart and blood vessels. This may help the heart to pump blood more effectively. This is the first study to explore its use specifically for children with heart failure and LVSD. The main purpose of this study is to learn if finerenone works to help the heart compared to placebo in children with heart failure and LVSD. For this, the researchers will collect and analyze data on the levels of a protein called NT-proBNP in the blood, which indicates heart stress, and monitor the safety of the treatment. The study will include children with heart failure and LVSD aged from 6 months to less than 18 years. The study participants will be randomly assigned to one of two treatment groups. Based on their group, they will receive either finerenone or a placebo for a duration of 3 months. A placebo looks like a treatment but does not have any medicine in it. Throughout the study, all participants will continue to receive their standard heart failure treatments. At the start of this study, the doctors will check each participant's medical history and current medications. If participants qualify for the treatment phase, they will undergo treatment for about 90 days. During this time, they will visit the study site at least 3 times. During these visits, the participants will: - have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured - have their heart examined by electrocardiogram (ECG) and echocardiogram - have blood samples taken - have physical examinations - answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answers An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. After the initial three-month study, eligible participants will have the option to join a nine-month open-label extension study where all will receive finerenone. Participants who choose not to enroll in the extension will have a follow-up visit 30 days after their last treatment. Type: Interventional Start Date: Nov 2025 |
|
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Modera1
Sanofi
Crohn's Disease
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3
study to evaluate the efficacy and safety of duvakitug in participants with moderately to
severely active Crohn's Disease (CD). Study details include:
The study duration may be up to 286 weeks including:
-1 expand
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include: The study duration may be up to 286 weeks including: - 40-week Pivotal Maintenance Sub-Study - 240-week Open-Label Extension (OLE) Sub-Study - 45-day Follow-Up visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: - 40 weeks in the Pivotal Maintenance Sub-Study - 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study Type: Interventional Start Date: Jan 2026 |
|
Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation
Medtronic Vascular
Hypertension
Cardiovascular Diseases
Vascular Diseases
This observational study will assess the long-term effectiveness of the RDN procedure for
lowering blood pressure in Medicare patients with uncontrolled hypertension. This
research will be conducted using de-identified electronic health records (EHR) and
administrative health insurance claims data.1 expand
This observational study will assess the long-term effectiveness of the RDN procedure for lowering blood pressure in Medicare patients with uncontrolled hypertension. This research will be conducted using de-identified electronic health records (EHR) and administrative health insurance claims data. Patients are enrolled through the submission of claims or encounter data to CMS. Type: Observational Start Date: Oct 2025 |
|
45th Multicenter Airway Research Collaboration
Massachusetts General Hospital
Asthma Acute
Asthma Exacerbation
Asthma
Asthma Control Level
The study is a randomized controlled trial on the effect of emergency department
initiation of Airsupra on acute asthma "recurrence" at 3 months and other related
outcomes (acute asthma relapse, asthma control). expand
The study is a randomized controlled trial on the effect of emergency department initiation of Airsupra on acute asthma "recurrence" at 3 months and other related outcomes (acute asthma relapse, asthma control). Type: Interventional Start Date: Nov 2025 |
|
M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Sel1
EMD Serono Research & Development Institute, Inc.
Advanced Solid Tumor
The purpose of this first-in-human study is to identify a recommend dose(s) for
subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing
doses of M0324, primarily looking at safety, but also preliminary signs of efficacy,
pharmacokinetics (PK), and pharmacodynamics (1 expand
The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a monotherapy(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3). Type: Interventional Start Date: Oct 2025 |
|
Clinical Trial to Reduce Perinatal Intimate Partner Violence
University of Pittsburgh
Domestic Violence
Perinatal Problems
This is a two-armed, fully powered hybrid type 1 trial to test the effectiveness of a
doula intervention compared with an active control in reducing intimate partner violence
(IPV) among perinatal IPV survivors expand
This is a two-armed, fully powered hybrid type 1 trial to test the effectiveness of a doula intervention compared with an active control in reducing intimate partner violence (IPV) among perinatal IPV survivors Type: Interventional Start Date: Nov 2025 |
|
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Live1
Eli Lilly and Company
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-invas1 expand
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. Type: Interventional Start Date: Oct 2025 |