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199 Clinical Trials near Clermont, 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 PowerSerplulimab + Chemotherapy for Small Cell Lung Cancer
Clermont, Florida
This trial is testing two different treatment combinations for patients with extensive-stage small cell lung cancer who have not received any prior treatment. One group will receive a new drug called Serplulimab along with standard chemotherapy, while the other group will receive an existing drug called Atezolizumab with the same chemotherapy. Both immunotherapy drugs aim to help the immune system fight cancer, and the chemotherapy drugs work by killing cancer cells. Atezolizumab has been shown to improve survival in small-cell lung cancer when combined with chemotherapy, changing the standard first-line therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Mixed SCLC, Severe Allergy, Myocardial Infarction, Others
Must Not Be Taking:Psychotropic Drugs
200 Participants Needed
Buntanetap for Alzheimer's Disease
Clermont, Florida
The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are:
* Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13?
* Does buntanetap/Posiphen improve function as measured by ADCS-iADL?
* What medical issues do participants have, if any, when taking buntanetap/Posiphen?
Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease.
Participants will:
* Take buntanetap/Posiphen or a placebo every day for 18 months
* Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18
* Complete pre- and post-clinic visit phone calls
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:55 - 85
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Major Depression, Others
Must Be Taking:Cholinesterase Inhibitors, Memantine
760 Participants Needed
Fianlimab + Cemiplimab + Chemotherapy for Non-Small Cell Lung Cancer
Clermont, Florida
This trial is testing a new drug called fianlimab with cemiplimab and chemotherapy in patients with advanced lung cancer. The goal is to see if this combination is more effective than current treatments. The new drugs help the immune system fight cancer, while chemotherapy attacks the cancer cells directly.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Brain Metastases, EGFR Mutations, Others
Must Not Be Taking:Corticosteroids, Immunosuppressants
950 Participants Needed
Fianlimab + Cemiplimab for Non-Small Cell Lung Cancer
Clermont, Florida
This trial is testing a new drug combination for patients with advanced lung cancer. It aims to see if using two drugs together is more effective than one alone. The study also looks at side effects, how the drugs are processed in the body, and their impact on quality of life.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Never Smoked, Brain Metastases, EGFR Mutations, Others
Must Not Be Taking:Corticosteroids, Immunosuppressants
850 Participants Needed
Rimegepant for Migraine Prevention in Children
Clermont, Florida
This trial is testing rimegepant, a medication that prevents migraines, in children and teens who have occasional migraines. It works by blocking a protein that causes migraine pain. Rimegepant is taken orally and has shown effectiveness in treating migraines.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Basilar Migraine, Cluster Headaches, Hemiplegic Migraine, Psychiatric Disorder, Substance Abuse, Others
640 Participants Needed
High-Dose vs Low-Dose Capsaicin for Neuropathic Pain
Clermont, Florida
This is an interventional, Phase III, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated topical application of Qutenza (capsaicin 8% topical system) versus low-dose capsaicin control (capsaicin 0.04% topical system) in subjects with moderate to severe postsurgical neuropathic pain (PSNP).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Severe Psychiatric Illness, Cognitive Impairment, Others
409 Participants Needed
Risankizumab for Ulcerative Colitis
Clermont, Florida
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs).
Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide.
For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study.
The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Crohn's Disease, Active Infection, Others
Must Not Be Taking:Targeted Therapies
530 Participants Needed
BNT327 + Chemotherapy for Small Cell Lung Cancer
Clermont, Florida
This is a Phase III, multisite, randomized, double-blinded study to investigate BNT327 combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Combined Histologies, Untreated Brain Metastases, Others
Must Not Be Taking:PD(L)-1/VEGF Antibodies, Corticosteroids
439 Participants Needed
BNT327 + Chemotherapy for Non-Small Cell Lung Cancer
Clermont, Florida
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).
This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Small-cell Lung Cancer, Uncontrolled Hypertension, Others
Must Not Be Taking:Anti-VEGF, PD(L)-1, Corticosteroids
982 Participants Needed
Remternetug for Alzheimer's Disease
Clermont, Florida
The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer's disease occurring in participants receiving study drug compared to placebo.
Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:65 - 80
Key Eligibility Criteria
Disqualifiers:Dementia, Neurological Disease, Cancer, Others
Must Not Be Taking:Anti-amyloid Immunotherapy
1200 Participants Needed
Dato-DXd + Rilvegostomig for Lung Cancer
Clermont, Florida
This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:EGFR Mutation, ALK Alteration, ILD, Others
660 Participants Needed
Pegozafermin for Liver Cirrhosis
Clermont, Florida
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Liver Disorder, Hepatic Decompensation, Hepatocellular Carcinoma, Diabetes, Others
762 Participants Needed
Solriamfetol for Binge Eating Disorder
Clermont, Florida
ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Prior Solriamfetol Exposure, Others
450 Participants Needed
Pegozafermin for Fatty Liver Disease
Clermont, Florida
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Chronic Liver Diseases, Cirrhosis, Diabetes, Others
1050 Participants Needed
Fianlimab + Cemiplimab for Melanoma
Clermont, Florida
This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drugs.
* How much study drug is in the blood at different times.
* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uveal Melanoma, Autoimmune Disease, HIV, Others
Must Not Be Taking:Immunosuppressants
560 Participants Needed
Nemtabrutinib for Chronic Lymphocytic Leukemia
Clermont, Florida
The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active HBV/HCV, CNS Involvement, Others
Must Not Be Taking:P-gp Substrates, CYP3A Inducers
1200 Participants Needed
KarXT for Alzheimer's-Related Psychosis
Clermont, Florida
This trial is testing KarXT, a medication for adults aged 55-90 with Alzheimer's Disease and severe psychosis. The goal is to see if KarXT can reduce symptoms like hallucinations and delusions by balancing brain chemicals.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:55 - 90
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Major Depression, Others
400 Participants Needed
Risankizumab for Crohn's Disease
Clermont, Florida
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants.
Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally.
Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Indeterminate Colitis, Others
Must Not Be Taking:P19 Inhibitors
276 Participants Needed
Lumateperone for Major Depressive Disorder
Clermont, Florida
This trial is testing lumateperone, a medication that may help people with depression who haven't improved with other treatments. The study includes patients diagnosed with Major Depressive Disorder who haven't responded well to their current antidepressants. Lumateperone works by balancing brain chemicals that affect mood, potentially improving depressive symptoms.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Anxiety, Others
Must Be Taking:Antidepressants
470 Participants Needed
Donanemab for Early Alzheimer's Disease
Clermont, Florida
This trial is testing different doses of donanemab, a drug aimed at helping people with early Alzheimer's disease. Donanemab has shown rapid reduction of brain amyloid in early Alzheimer's disease. The study will look at how often and how severely participants experience a side effect involving brain swelling. Researchers also want to find out which patient characteristics might predict this side effect.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60 - 85
Key Eligibility Criteria
Disqualifiers:Not Listed
800 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 changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"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 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
"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
SC Pembrolizumab + Hyaluronidase for Non-Small Cell Lung Cancer
Clermont, Florida
This trial compares two methods of administering a cancer drug in adults with advanced lung cancer. It aims to see if injecting the drug under the skin is as effective as giving it directly into a vein. The drug helps the immune system attack cancer cells by blocking a specific protein.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Small Cell Lung Cancer, Autoimmune, Others
Must Not Be Taking:Corticosteroids, Immunosuppressants
377 Participants Needed
Nemtabrutinib for Chronic Lymphocytic Leukemia
Clermont, Florida
Researchers are looking for new ways to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer. Researchers want to know if people who take nemtabrutinib compared to those who take the standard treatments in this study will live longer without their cancer growing, spreading or returning (progression free survival).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Hepatitis B/C, Malignancy, Bleeding, Others
300 Participants Needed
This trial compares pembrolizumab alone and in combination with sacituzumab govitecan in adults with advanced lung cancer who have high levels of a certain protein. Pembrolizumab boosts the immune system to fight cancer, while sacituzumab govitecan targets and kills cancer cells. Pembrolizumab has been used as a standard treatment for a type of lung cancer, showing improved survival rates compared to other treatments.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Second Malignancy, Cardiac Disease, Autoimmune, Others
Must Not Be Taking:Topoisomerase Inhibitors, Trop-2 Therapy
614 Participants Needed
AR1001 for Alzheimer's Disease
Clermont, Florida
This trial tests AR1001, a medicine for early Alzheimer's Disease. It focuses on people in the early stages of Alzheimer's, aiming to improve their condition through multiple mechanisms.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:55 - 90
Key Eligibility Criteria
Disqualifiers:Pregnancy, Delirium, Schizophrenia, Cancer, Others
Must Be Taking:Cholinesterase Inhibitors, Memantine
1150 Participants Needed
KarXT for Alzheimer's-Associated Psychosis
Clermont, Florida
This trial is testing KarXT, a medication, to see if it can prevent psychotic symptoms from returning in people with Alzheimer's Disease. It works by balancing brain chemicals that cause hallucinations and delusions. KarXT has shown positive results in reducing symptoms of schizophrenia.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:55 - 90
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Severe Renal Impairment, Others
Must Be Taking:Cholinesterase Inhibitors, Memantine
380 Participants Needed
Imlunestrant + Abemaciclib for Breast Cancer
Clermont, Florida
This trial is testing a new drug called imlunestrant, alone and in combination with another drug, abemaciclib, for patients with advanced breast cancer that is ER+ and HER2-. Imlunestrant works by blocking estrogen receptors on cancer cells, while abemaciclib stops the cells from multiplying. The goal is to see if these treatments work better than standard hormone therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Visceral Crisis, Brain Metastasis, Others
Must Be Taking:Aromatase Inhibitors
874 Participants Needed
AVP-786 for Alzheimer's-related Agitation
Clermont, Florida
This trial tests a combination of two drugs taken by mouth to help calm severe agitation in people with Alzheimer's disease by balancing brain chemicals.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50 - 90
Key Eligibility Criteria
Disqualifiers:Non-Alzheimer's Dementia, Unstable Systemic Diseases, Myasthenia Gravis, Others
241 Participants Needed
Risankizumab for Ulcerative Colitis
Clermont, Florida
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.
This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:16 - 80
Key Eligibility Criteria
Disqualifiers:Hypersensitivity, Non-compliance, Others
Must Be Taking:Risankizumab
1242 Participants Needed
Risankizumab for Crohn's Disease
Clermont, Florida
This trial tests risankizumab, a medication for Crohn's disease, in patients who have already responded well to it. The goal is to see if continued use can maintain their improvement by reducing inflammation in the digestive tract. Risankizumab is approved by the FDA for treating moderate to severe Crohn's disease.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:16 - 80
Key Eligibility Criteria
Disqualifiers:Colonic Dysplasia, Colon Cancer, Lymphoproliferative Disease, Others
Must Be Taking:Risankizumab
1336 Participants Needed
Survodutide for Fatty Liver Disease
Clermont, Florida
This study is open to adults who are at least 18 years old and have:
* a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic-associated steatohepatitis (MASH) and
* moderate or advanced liver fibrosis
People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.
This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function.
Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the 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. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Other Liver Diseases, Liver Cirrhosis, Hepatocellular Carcinoma, Others
Must Not Be Taking:Obesity Medications
1800 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
Bask GillCEO at Power
Frequently Asked Questions
How much do clinical trials in Clermont, FL pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do clinical trials in Clermont, FL work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials in Clermont, FL 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in Clermont, FL is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in Clermont, FL several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a medical study in Clermont, FL?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest clinical trials in Clermont, FL?
Most recently, we added Vicadrostat + Empagliflozin for Chronic Kidney Disease, Risankizumab for Ulcerative Colitis and PDS0101 + Pembrolizumab for Head and Neck Cancer to the Power online platform.
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