A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes
NCT06993792 · Obesity, Overweight, Type 2 Diabetes
RecruitingThe purpose of this Master Protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1, NCT06972459 (do not have type 2 diabetes) or J2A-MC-GZP2, NCT06972472 (have type 2 diabetes).
PhasePhase 3
TypeInterventional
Age18 Years
WhereSun City West, Arizona, United States + 79 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Adapting and Assessing the Feasibility of a Telehealth Diabetes Prevention Program for Hispanic Adolescents
NCT06943001 · Obesity and Type 2 Diabetes
RecruitingHispanic adolescents are disproportionately burdened by type 2 diabetes (T2D). Social determinants of health (SDoH) serve as barriers to behavior change and participation in disease prevention efforts, especially among vulnerable adolescents. Telehealth is a potentially effective approach for delivering disease prevention programs as it addresses some SDoH like transportation, childcare needs, and parent work schedules. Unfortunately, there are no theory- or evidence-based telehealth diabetes prevention program for Hispanic adolescents. Therefore the purpose of this study is to adapt an evidence-based diabetes prevention program for delivery via telehealth and to test the feasibility of this study among Hispanic adolescents (12-16 years) with obesity.
PhaseNA
TypeInterventional
Age14 Years – 16 Years
WhereHouston, Texas, United States
SponsorBaylor College of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents
NCT06959901 · Obesity and Diabetes Mellitus, Type 2, Diabetes Prevention
RecruitingHispanic adolescents in the U.S. are disproportionately burdened by type 2 diabetes (T2D) compared to non-Hispanic white youth (0.079% vs. 0.017%) contributing to higher rates of T2D-related vascular complications, cardiovascular disease, and mortality, among this population. Disparities in T2D are driven in part by independent, modifiable risk factors including low levels of physical activity, sleep, and poor diet. Lifestyle interventions are the cornerstone for maintaining glucose control and managing T2D. However, few studies have developed and tested lifestyle interventions for Hispanic youth with T2D. Digital health interventions that promote healthy lifestyle behaviors like physical activity, sleep, and diet, have demonstrated effectiveness among adults. Studies that use health-based smartphone applications have demonstrated preliminary efficacy for improving health-related lifestyle behaviors as these digital tools leverage behavior change techniques (e.g. self-monitoring, goal-setting, feedback) that have proven effective. Use of digital technology allows for the continuous delivery of intervention content into the home environment extending the reach of clinical care while engaging youth in a format that is age-appropriate given that today's youth are digital frontrunners. Unfortunately, while the use of digital health interventions have increased, few studies have focused on adolescents with overweight and obesity who are at high risk for T2D. The purpose of this study is to 1) develop a mobile health platform for remote and continuous monitoring of activity, sleep, and nutrition and 2) conduct a pilot study (30 days) to evaluate the efficacy of a novel digital health platform in improving obesity-related health outcomes outcomes in Hispanic adolescents (12-18 years; N=30) population.
PhaseNA
TypeInterventional
Age12 Years – 18 Years
WhereHouston, Texas, United States
SponsorBaylor College of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts Aleniglipron Phase 2 in Type 2 Diabetes Mellitus
NCT07400588 · Obese, Obesity, Obesity Type 2 Diabetes Mellitus
RecruitingThe purpose of this study is to assess the safety and tolerability of aleniglipron at doses up to 240 mg once daily (QD) in participants with T2DM who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2).
PhasePhase 2
TypeInterventional
Age18 Years – 79 Years
WhereAnniston, Alabama, United States + 16 more
SponsorGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis
NCT05950282 · Insulin Resistance, Polycystic Ovary Syndrome, Hyperinsulinism
RecruitingThe study aims to investigate the relationship between fasting insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) across various demographic factors, including age, sex, race/ethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis. By analyzing these variables, the study seeks to identify potential variations in insulin levels, which could provide valuable insights into the impact of different factors on metabolic health and the development of insulin-related conditions.
Phase—
TypeObservational
Age18 Years
WhereHouston, Texas, United States
SponsorLilli Health
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
NCT05142189 · Non-Small Cell Lung Cancer
RecruitingThis first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and/or in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor, an anti-human epidermal growth factor receptor 3 (HER3) antibody conjugated to a topoisomerase I inhibitor or a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) in participants with non-small cell lung cancer (NSCLC). The study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The study will enroll participants with NSCLC in advanced or metastatic stage in Cohorts 1 to 4 and Cohorts 7 to 10, unresectable NSCLC Stage III in Cohorts 5 and 11, resectable NSCLC of Stage II and III in Cohort 6, advanced/metastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced/metastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK/RET. Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLexington, Kentucky, United States + 43 more
SponsorBioNTech SE
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
NCT07502495 · Type 2 Diabetes
RecruitingThis is a Phase 2, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes who are not achieving glycemic targets despite antihyperglycemic medications.
PhasePhase 2
TypeInterventional
Age18 Years – 70 Years
WhereBirmingham, Alabama, United States + 14 more
SponsorBiomea Fusion Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes
NCT07282600 · Overweight, Obesity
RecruitingThe main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 158 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes
NCT06972472 · Obesity, Overweight, Type 2 Diabetes
RecruitingThe main purpose of this study is to see how orforglipron, compared with placebo, helps improve glycemic control in participants with obesity or with overweight and type 2 diabetes. This trial is part of the master protocol study J2A-MC-GZPO. Participation in the study will last about 18 months.
PhasePhase 3
TypeInterventional
Age18 Years
WhereSun City West, Arizona, United States + 76 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin
NCT07215312 · Diabetes Mellitus, Type 2
RecruitingThe purpose of this study is to see how well LY3938577 works and how safe it is compared to degludec in people with type 2 diabetes. Participation in the study will last about 26 weeks.
PhasePhase 2
TypeInterventional
Age18 Years – 70 Years
WhereTucson, Arizona, United States + 25 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome
NCT07219602 · Lipidemia, Type 2 Diabetes (T2DM), Metabolic Syndrome (MetS)
RecruitingThis study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and/or Type 2 Diabetes Mellitus.
PhasePhase 3
TypeInterventional
Age18 Years
WhereSun City West, Arizona, United States + 19 more
SponsorNewAmsterdam Pharma
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
NCT06972459 · Obesity, Overweight
RecruitingThe main purpose of this study is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding type 2 diabetes). This trial is part of the master protocol study J2A-MC-GZPO (NCT06993792). Participation in the study will last about 18 months.
PhasePhase 3
TypeInterventional
Age18 Years
WhereSun City West, Arizona, United States + 79 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
NCT07064473 · Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases
RecruitingThis study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAnniston, Alabama, United States + 1150 more
SponsorBoehringer Ingelheim
▾Tap for detailsClick for full details — eligibility, all locations, contacts Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
NCT05099770 · Type 2 Diabetes Mellitus, Chronic Kidney Diseases
RecruitingThe purpose of this study is to assess the safety and efficacy of up to 2 REACT/rilparencel injections in participants with T2DM and CKD.
PhasePhase 3
TypeInterventional
Age30 Years – 80 Years
WhereHuntsville, Alabama, United States + 94 more
SponsorProkidney
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes
NCT07215559 · Obesity, Overweight, Diabetes Mellitus, Type 2
RecruitingThe purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereGilbert, Arizona, United States + 37 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes
NCT06267391 · Type 2 Diabetes Mellitus, Type2diabetes, Diabetes Mellitus, Type 2
RecruitingThis study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.
PhaseNA
TypeInterventional
Age22 Years – 70 Years
WhereBirmingham, Alabama, United States + 44 more
SponsorEndogenex, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes
NCT07321886 · Obesity, Overweight
RecruitingThe purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.
PhasePhase 3
TypeInterventional
Age18 Years
WhereTuscaloosa, Alabama, United States + 172 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Arginine Metabolism in Youth With Type 2 Diabetes
NCT05477134 · Type 2 Diabetes
RecruitingType 2 diabetes (T2D), once considered only "a disease of older ages," is now a significant public health concern in youth. Although it is characterized by insulin resistance and impaired insulin secretion, its precise etiology and pathogenesis are not yet fully understood. This study aims to (1) explore arginine metabolism in youth with T2D via safe, minimally invasive kinetic experiments using stable isotope tracers and targeted metabolomics, and (2) determine the effect of exogenous arginine administration on β-cell function in youth with T2D, potentially supporting the use of this safe, low-cost, and readily available nutrient to improve pediatric diabetes outcomes.
PhaseNA
TypeInterventional
Age12 Years – 20 Years
WhereHouston, Texas, United States
SponsorBaylor College of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease
NCT07271186 · Diabetic Kidney Disease (DKD)
RecruitingThis study is researching experimental drugs called ALN-ANG3 and evinacumab (called "study drugs"). The study is focused on participants who have diabetic kidney disease. The aim of the study is to see how safe and effective the study drugs are. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times
PhasePhase 2
TypeInterventional
Age18 Years – 80 Years
WhereLittle Rock, Arkansas, United States + 38 more
SponsorRegeneron Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
NCT07296484 · Type 2 Diabetes, Cortisol Excess
RecruitingCAPTAIN-T2D will take place in two parts. Part 1 (Screening) will evaluate patients with type 2 diabetes and elevated cortisol risk factors for trial eligibility and the presence of elevated cortisol. Participants deemed eligible from Part 1 will be randomized to either clofutriben or placebo in the double-blind (participant and investigator), dose-ranging, interventional Part 2 (Treatment).
PhasePhase 2
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 45 more
SponsorSparrow Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts