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220 Clinical Trials near Aurora, CO
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.
Bionetide for Rett Syndrome
Aurora, ColoradoPrimary Objective • To investigate the efficacy of treatment with oral Bionetide versus placebo in girls and women with Rett syndrome
Key Secondary Objective
• To investigate the efficacy of treatment with oral Bionetide versus placebo on ability to communicate in girls and women with Rett syndrome
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:5 - 20
Sex:Female
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Endocrine, Renal, Others
Must Not Be Taking:Insulin
210 Participants Needed
Infigratinib for Dwarfism
Aurora, ColoradoACCEL2/3 is a Phase 2/3 study. The purpose of the Phase 2 portion of the study (ACCEL2/3) is to evaluate the efficacy and safety, of infigratinib in children with hypochondroplasia (HCH) receiving infigratinib, at one of two doses, of who have completed at least 26 weeks of participation in QED-sponsored ACCEL (QBGJ398-004).
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2, 3
Age:3 - 18
Sex:All
24 Participants Needed
Tirzepatide for Type 1 Diabetes and Obesity
Aurora, ColoradoThe main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.
Pivotal Trial
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
905 Participants Needed
Mindfulness-Based Intervention for Type 1 Diabetes
Aurora, ColoradoType 1 diabetes (T1D) is a common chronic illness among children requiring a high degree of self-management for good glycemic control. Adolescents are at risk for poor disease management and health outcomes due to a number of factors, including high rates of depression, anxiety, and stress. Accessing support for these challenges can be a barrier to care, so the current study, BRinging Empowerment and Attention to Teen HEalth-T1D, evaluates the efficacy of a virtual, group-based mindfulness based intervention and a virtual group-based diabetes education intervention on improving symptoms of depression and anxiety, and diabetes self management in teens with T1D. The study also aims to study how these interventions might be implemented in diabetes clinic settings.
Pivotal Trial
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2, 3
Age:13 - 17
Sex:All
200 Participants Needed
D-Fi for Epidermolysis Bullosa
Aurora, ColoradoThe purpose of this study is to determine whether administration of D-Fi in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Dystrophic Epidermolysis Bullosa.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2+
Sex:All
32 Participants Needed
Inhaled Insulin for Gestational Diabetes
Aurora, ColoradoPregnant women aged 18-49 with gestational diabetes (GDM) will take part in this study. We want to see how two different insulin treatments affect their blood sugar after they eat. These women usually use a rapid-acting insulin analog (RAA) that's injected to control their blood sugar before and after meals. They will come to the clinic for two meal sessions. For the first meal, we will randomly decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin (TI). They will use the other type of insulin for their second meal. After each meal, we will compare their blood sugar levels.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2, 3
Age:18 - 49
Sex:Female
30 Participants Needed
LevoCept for Birth Control
Aurora, ColoradoTo assess the contraceptive efficacy (prevention of pregnancy) of LevoCept
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:< 45
Sex:Female
1525 Participants Needed
Benralizumab for Eosinophilic Diseases
Aurora, ColoradoThe main purpose of study is to assess the safety, tolerability, and pharmacokinetic (PK) of benralizumab.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:6 - 17
Sex:All
14 Participants Needed
Amivantamab + FOLFIRI for Colorectal Cancer
Aurora, ColoradoThe purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.
No Placebo Group
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:ILD, Second Malignancy, HER2-positive, Others
Must Not Be Taking:Irinotecan, EGFR Agents, MET Agents
700 Participants Needed
CAB LA + RPV LA for HIV Infection
Aurora, ColoradoThis study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Hepatitis B, Hepatitis C, Others
Must Be Taking:Oral ART
332 Participants Needed
Retatrutide vs Tirzepatide for Obesity
Aurora, ColoradoThe main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Obesity Surgery, Thyroid Cancer, Pancreatitis, Others
Must Not Be Taking:Weight Loss Drugs
800 Participants Needed
Sotagliflozin for Diabetic Kidney Disease
Aurora, ColoradoPowerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Type 2 Diabetes, DKA History, Others
Must Be Taking:Insulin, RASB
150 Participants Needed
CDK4/6 Inhibitors for Metastatic Breast Cancer
Aurora, ColoradoThe purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs.
The primary objective of the CDK Study is to compare time to treatment discontinuation (TTD) on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice endocrine therapy (aromatase inhibitor (AI) or fulvestrant) in patients age 65 or older with HR+/HER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors.
Together with their treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing).
No Placebo Group
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:65+
Sex:All
Key Eligibility Criteria
Disqualifiers:Previous CDK4/6, Brain Metastases, Others
Must Be Taking:CDK4/6 Inhibitors
500 Participants Needed
Remternetug for Alzheimer's Disease
Aurora, ColoradoThe 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
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:65 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Dementia, Neurological Disease, Cancer, Others
Must Not Be Taking:Anti-amyloid Immunotherapy
1200 Participants Needed
Orforglipron for Obstructive Sleep Apnea
Aurora, ColoradoStudy GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight. Study GZ01 will include participants who are unable or are unwilling to use PAP therapy. Study GZ02 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Upper Airway Surgery, Others
600 Participants Needed
RMC-6236 for Pancreatic Cancer
Aurora, ColoradoThe purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Major Surgery, Others
Must Not Be Taking:RAS-targeted Therapy
460 Participants Needed
Bionic Pancreas for Cystic Fibrosis
Aurora, ColoradoThis multi-center randomized controlled trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas System (BP) versus a control group using their usual care insulin delivery method and continuous glucose monitoring (CGM) during a 13-week study period in individuals ≥14 years old with cystic fibrosis-related diabetes (CFRD). After 13 weeks, participants will continue in a 13-week Extension Phase in which the BP group will continue to use the BP system and the Usual Care group will initiate use of the BP system.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:14+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Transplant, Severe Liver Disease, Others
Must Be Taking:Insulin
150 Participants Needed
Brepocitinib for Uveitis
Aurora, ColoradoThe purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Lymphoproliferative Disorder, Active Malignancy, Others
300 Participants Needed
Immunotherapy + Chemotherapy for Sarcoma
Aurora, ColoradoThis phase II trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable UPS or a related poorly differentiated sarcoma live longer without having disease progression.
No Placebo Group
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Interstitial Lung Disease, Others
Must Not Be Taking:Steroids, Anthracyclines
180 Participants Needed
Sacituzumab Govitecan for Endometrial Cancer
Aurora, ColoradoThe goal of this clinical study is to find out how the study drug, sacituzumab govitecan (SG) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy, versus the treatment of physician's choice (TPC).
The primary objectives of this study are to evaluate the effect of SG compared to TPC on progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS).
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Uterine Leiomyosarcoma, Active Second Malignancy, Others
Must Not Be Taking:Trop-2 ADCs
520 Participants Needed
Zanidatamab vs Trastuzumab for Breast Cancer
Aurora, ColoradoThe efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Leptomeningeal Disease, Cardiovascular, HIV, Others
Must Not Be Taking:Antineoplastics, Hormonal Therapies
550 Participants Needed
Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed.
Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide.
Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
No Placebo Group
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Active Infection, Richter's Transformation, Others
Must Be Taking:Venetoclax
120 Participants Needed
Debio 4326 for Precocious Puberty
Aurora, ColoradoThis trial is testing an injectable medication called Debio 4326. It is aimed at children who start puberty too early and are already receiving another treatment. The goal is to lower a hormone that triggers puberty, helping to delay its onset.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:5 - 8
Sex:All
Key Eligibility Criteria
Disqualifiers:Peripheral Precocious Puberty, Intracranial Tumor, Diabetes, Seizures, Others
Must Be Taking:GnRHa Therapy
53 Participants Needed
Upadacitinib for Crohn's Disease
Aurora, ColoradoCrohn'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 oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.
Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide.
Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Abscess, Bowel Strictures, Others
110 Participants Needed
Saroglitazar Magnesium for Primary Biliary Cirrhosis
Aurora, ColoradoOpen-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Liver Diseases, Cirrhosis, Cardiovascular, Others
Must Not Be Taking:Thiazolidinediones, Fibrates, PPAR Agonists, Others
150 Participants Needed
Ivosidenib for Chondrosarcoma
Aurora, ColoradoStudy CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants.
Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Brain Metastases, Cardiac Disease, Others
Must Not Be Taking:IDH1 Inhibitors, Steroids
136 Participants Needed
Psilocybin for Depression
Aurora, ColoradoThe purpose of this study is to evaluate the efficacy of psilocybin on the symptom of anhedonia in individuals with treatment-resistant major depressive disorder.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:21 - 75
Sex:All
40 Participants Needed
AR882 for Gout
Aurora, ColoradoThis study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 85
Sex:All
Key Eligibility Criteria
Disqualifiers:Malignancy, Pregnant, Kidney Stones, Others
750 Participants Needed
Ziltivekimab for Heart Attack
Aurora, ColoradoThe research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Chronic Heart Failure, Severe Kidney Impairment, Severe Hepatic Disease, Others
10000 Participants Needed
Amino Acids for Fatty Liver Disease
Aurora, ColoradoParticipants 13-18 years of age with extra fat stored in the liver will be randomly assigned to a protein supplement or placebo "fake supplement" for 2 months to see if the participants who get the protein supplement have less fat in the liver compared to participants who were in the placebo group. After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:13 - 18
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Anemia, Others
Must Not Be Taking:Metformin, Glucocorticoids, Antipsychotics, Others
55 Participants Needed
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Frequently Asked Questions
How much do clinical trials in Aurora, CO 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 Aurora, CO 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 Aurora, CO 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 Aurora, CO 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 Aurora, CO 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 Aurora, CO ?
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 Aurora, CO ?
Most recently, we added Bionetide for Rett Syndrome, Infigratinib for Dwarfism and Tirzepatide for Type 1 Diabetes and Obesity to the Power online platform.