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184 Clinical Trials near Miami, FL
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerCOVID-19 Vaccine + RSV Vaccine for Adults 50+
Coral Gables, Florida
This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Not Listed
842 Participants Needed
Survodutide for Obesity and Fatty Liver Disease
Miami, Florida
This study is open to adults who are at least 18 years old and have
* presumed or confirmed NASH together with overweight or obesity and
* a body mass index (BMI) of 30 kg/m² or more, or
* a BMI of 27 kg/m² and at least one weight-related health problem.
People with a history of other chronic liver diseases cannot take part in this study.
The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 14 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Chronic Liver Diseases, Cirrhosis, Others
Must Not Be Taking:Liver Injury Drugs
248 Participants Needed
BHV-7000 for Epilepsy
Miami, Florida
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Status Epilepticus, Cluster Seizures, Others
Must Be Taking:Anti-seizure Medications
390 Participants Needed
Efgartigimod for Thyroid Eye Disease
Miami, Florida
This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.
After the screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded treatment period (DBTP). At the end of the DBTP, participants may enter a follow-up observational period while off study drug. Some participants may also enter the open-label treatment period with efgartigimod PH20 SC. The study duration varies from approximately 60 to 110 weeks.
An alternative list of clinical sites open for recruitment could be found in the other UplighTED study record (https://www.clinicaltrials.gov/study/NCT06307626)
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Optic Neuropathy, Corneal Decompensation, Autoimmune Disease, Others
123 Participants Needed
ALZ-801 for Early Alzheimer's Disease
Miami Beach, Florida
This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50 - 85
Key Eligibility Criteria
Disqualifiers:Moderate-severe ARIA, Others
Must Not Be Taking:Amyloid Antibodies
163 Participants Needed
Efgartigimod for Myasthenia Gravis
Miami, Florida
The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). The study consists of a Part A where participants will be randomized to receive either efgartigimod IV or placebo IV and a Part B where participants completing part A will receive open-label efgartigimod IV. Participants will be in the study for up to (approximately) 2.5 years.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Autoimmune Disease, Cancer, HIV, Others
Must Be Taking:Acetylcholinesterase Inhibitors, Steroids
119 Participants Needed
ZILRETTA for Shoulder Osteoarthritis
Maimi, Florida
Primary Objective: To assess the efficacy of ZILRETTA on pain following an intra-articular (IA) injection in subjects with glenohumeral osteoarthritis (OA) relative to normal saline placebo
Secondary Objective:
* To assess the efficacy of ZILRETTA on pain following an IA injection in subjects with glenohumeral OA relative to triamcinolone acetonide injectable suspension, and normal saline placebo
* To assess the safety of ZILRETTA in subjects with glenohumeral OA relative to normal saline placebo
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:50 - 80
Key Eligibility Criteria
Disqualifiers:Symptomatic Arthritis, Rotator Cuff Pathology, Chronic Shoulder Pain, Others
Must Not Be Taking:Opioids, Analgesics, THC/CBD, SSRIs/SNRIs
150 Participants Needed
Pelacarsen for Cardiovascular Disease
Miami, Florida
Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uncontrolled Hypertension, Heart Failure, Malignancy, Others
Must Be Taking:LDL-C Lowering
422 Participants Needed
Salbutamol Inhalers for Asthma
Miami, Florida
The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged \>=18 years with asthma
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Life-threatening Asthma, Chronic Liver Disease, Others
Must Be Taking:Inhaled Corticosteroids, Short-acting Beta-agonists
412 Participants Needed
NRCT-101SR for ADHD
Miami, Florida
To evaluate the efficacy and safety of NRCT-101SR compared to placebo in subjects 13-17 years of age with ADHD
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:13 - 17
Key Eligibility Criteria
Disqualifiers:Severe Psychiatric Symptoms, Seizures, Substance Abuse, Others
160 Participants Needed
Fazirsiran for Alpha-1 Antitrypsin Deficiency
Miami, Florida
The liver produces a protein called alpha-1 antitrypsin (AAT). AAT is normally released into the bloodstream. In some people, the liver makes an abnormal version of the AAT protein, called Z-AAT. Making an abnormal version of the AAT protein can result in liver disease as Z-AAT builds up in liver cells, which leads to liver problems such as liver scarring (fibrosis), continuing liver damage (cirrhosis), and eventually end stage liver disease. Fazirsiran is a medicine that reduces the creation of the Z-AAT protein and thus the build-up of this abnormal protein in the liver. People with this type of liver disease who already have mild liver scarring will take part in the study. They will be treated with fazirsiran or a placebo for about 2 years. This study will check the long-term safety of fazirsiran, whether participants tolerate the treatment and if there are any effects on liver scarring. A liver biopsy, a way of collecting a small tissue sample from the liver, will be taken twice during the study.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Liver Fibrosis, Chronic Liver Diseases, Malignancy, Others
50 Participants Needed
SkinTE for Diabetic Foot Ulcers
Miami, Florida
The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Gangrene, Cancer, Radiation, Others
Must Be Taking:Oral Diabetes Medications
100 Participants Needed
BHV-7000 for Epilepsy
Miami, Florida
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Status Epilepticus, Cluster Seizures, Others
Must Be Taking:Anti-seizure Medications
390 Participants Needed
Chemotherapy for Pancreatic Cancer
Miami Beach, Florida
This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body (metastatic) and a known genetic mutation in the BRCA1, BRCA2, or PALB2 gene.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Active Brain Metastases, Others
Must Not Be Taking:CYP3A4 Inhibitors, CYP3A4 Inducers
100 Participants Needed
Linsitinib for Thyroid Eye Disease
Miami, Florida
This trial is testing linsitinib, a medication, on patients who did not improve or got worse after previous treatment. The goal is to see if linsitinib can help these patients by blocking certain proteins that make their condition worse.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Bipolar, Others
75 Participants Needed
IMC-F106C vs Nivolumab for Melanoma
Miami, Florida
This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Other Cancers, CNS Metastases, Others
Must Not Be Taking:Immunosuppressants
680 Participants Needed
Avutometinib + Defactinib for Ovarian Cancer
Miami Beach, Florida
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:High-grade Serous Cancer, Brain Metastases, Heart Disease, Lung Disease, Others
Must Not Be Taking:Steroids, FAK Inhibitors
270 Participants Needed
BI 456906 for Obesity
Coral Gables, Florida
This study is open to adults who are at least 18 years old and have
* a body mass index (BMI) of 30 kg/m² or more, or
* a BMI of 27 kg/m² or more and at least one health problem related to their weight.
People with type 2 diabetes cannot take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate.
The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. The results are compared between the groups to see whether the treatment works.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Type 2 Diabetes, Heart Failure, Others
Must Not Be Taking:Obesity Medications, Glucose-lowering Agents
726 Participants Needed
Durvalumab + Chemotherapy for Breast Cancer
Miami Beach, Florida
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Active Autoimmune, Others
Must Not Be Taking:Live Vaccines
3680 Participants Needed
Ecopipam for Tourette Syndrome
Miami, Florida
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to \[\>=\] 6 and less than \[\<\] 12 years of age), adolescents (\>=12 and \<18 years of age), and adults (\>=18 years of age) with Tourette's Syndrome (TS).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:6+
Key Eligibility Criteria
Disqualifiers:Neurological Conditions, Mood Disorders, Others
Must Be Taking:Ecopipam
150 Participants Needed
Why Other Patients Applied
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
Sigvotatug Vedotin vs Docetaxel for Lung Cancer
Miami, Florida
This trial is testing a new drug, sigvotatug vedotin, against a standard drug, docetaxel, in patients with advanced lung cancer. The goal is to see if the new drug works better and to understand its side effects. Docetaxel (Taxotere) is a well-established chemotherapy agent used in the treatment of advanced non-small cell lung cancer (NSCLC), often after failure of first-line treatments.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Life Expectancy < 3 Months, Respiratory Conditions, Peripheral Neuropathy, Uncontrolled Diabetes, Others
Must Be Taking:Platinum-based Chemotherapy, Anti-PD-(L)1
703 Participants Needed
Darovasertib + Crizotinib for Uveal Melanoma
Miami, Florida
This trial is testing a new drug combination (IDE196 and crizotinib) on patients with a specific type of eye cancer that has spread. The goal is to see if this combination can stop or slow down the cancer better than other treatments. Crizotinib has been used in treating various cancers with ALK gene rearrangements, showing high response rates.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Concurrent Malignant Disease, CNS Metastases, AIDS, Others
Must Not Be Taking:PKC Inhibitors, MET Inhibitors
420 Participants Needed
Blood Test and Immunotherapy for Bladder Cancer
Miami Beach, Florida
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Autoimmune Disease, Hepatitis, Myocarditis, Others
Must Be Taking:Immunotherapy
992 Participants Needed
The purpose of this research is to compare two outpatient pain management strategies in patients undergoing spinal surgeries such as microdiscectomies, foraminotomies, and spinal decompressions.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Liver Disease, Kidney Disease, Others
Must Be Taking:Pain Control Analgesics
100 Participants Needed
OCU410ST for Stargardt Disease
Miami, Florida
This trial tests OCU410ST, a treatment using a harmless virus to deliver a helpful gene into the eye, for children and young adults with Stargardt disease. The gene helps manage fat buildup, stress, and inflammation in the eye.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:5 - 65
Key Eligibility Criteria
Disqualifiers:Gene Therapy, Cell Therapy, Others
Must Not Be Taking:Retroviral Therapy
51 Participants Needed
IS-001 for Ureter Injury
Miami, Florida
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Hepatitis B/C, Others
237 Participants Needed
Tinengotinib for Bile Duct Cancer
Miami Beach, Florida
This trial is testing an oral medication called Tinengotinib for patients with a specific type of bile duct cancer that has not responded to other treatments. The medication works by blocking a protein that helps cancer cells grow. The goal is to see if Tinengotinib can slow down or stop the cancer in these patients.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Brain Metastases, Concurrent Malignancy, Others
Must Be Taking:FGFR Inhibitors
200 Participants Needed
Retatrutide for Obesity
Miami, Florida
This trial is testing a weekly medication called retatrutide. It aims to help people who are overweight or obese and have knee osteoarthritis. The study will last over a year to see if the medication is safe and effective.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Steroid Injections, Joint Disease, Diabetes, Others
Must Not Be Taking:Weight Loss Drugs
405 Participants Needed
Shorter Chemo-Immunotherapy Without Anthracyclines for Breast Cancer
Miami Beach, Florida
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Uncontrolled Diabetes, Others
Must Not Be Taking:Anti-PD-1, Anti-PD-L1
2400 Participants Needed
Retatrutide for Obesity
Miami, Florida
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Diabetes, Thyroid Carcinoma, Pancreatitis, Others
Must Not Be Taking:Weight Loss Drugs, Stimulants, Hypnotics, Others
2300 Participants Needed
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