RESET System Pivotal Trial (Rev F)
NCT04101669 · Diabetes type2, Obesity
RecruitingA Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study. A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (RESET):1 (Sham).
PhaseNA
TypeInterventional
Age22 Years – 65 Years
WhereWashington D.C., District of Columbia, United States + 6 more
SponsorMorphic Medical Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes
NCT07415954 · Diabetes Mellitus, Type 2
RecruitingThis study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereLancaster, California, United States + 62 more
SponsorNovo Nordisk A/S
▾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
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 + 15 more
SponsorBiomea Fusion Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)
NCT06906627 · Chronic Kidney Disease(CKD), Type 2 DM,
Type 2 Diabetes Mellitus (T2DM) RecruitingIRIS-CKD is an implementation study to improve guideline-recommended screening of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.
PhaseNA
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 6 more
SponsorDuke University
▾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 + 59 more
SponsorSparrow Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
RecruitingThe main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.
PhasePhase 3
TypeInterventional
Age10 Years – 17 Years
WhereTucson, Arizona, United States + 50 more
SponsorEli Lilly and Company
▾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 + 161 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy
RecruitingThis is a phase 2 randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes (T2D) not achieving glycemic targets despite Ozempic-based therapy.
PhasePhase 2
TypeInterventional
Age18 Years – 70 Years
WhereBirmingham, Alabama, United States + 16 more
SponsorBiomea Fusion Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
RecruitingThe purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WherePhoenix, Arizona, United States + 59 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases
NCT06451757 · Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD), Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like Episodes (MELAS)
RecruitingThe KHENERFIN study aims to determine whether the study medicine, sonlicromanol, is able to reduce symptoms of fatigue and the impact of fatigue on daily life, and whether sonlicromanol is able to improve physical abilities of people like balance control and lower limb skeletal muscle strength in people with mitochondrial disease. In this study, the effects of sonlicromanol are compared against a placebo, a tablet identical in appearance and taste but without the active drug. Participants take either sonlicromanol or placebo twice daily for a treatment duration of 52 weeks. In addition to these primary objectives, the study evaluates the efficacy of sonlicromanol on secondary and exploratory outcomes, as well as its safety and tolerability after one year of treatment.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 9 more
SponsorKhondrion BV
▾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 Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes
NCT07668388 · Diabetes Mellitus, Type 2
RecruitingThe study is testing UBT251 in participants with type 2 diabetes. The purpose of this clinical study is to find out if UBT251 is effective and safe for treating participants with type 2 diabetes. Participants will either get UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. Which treatment participants get is decided by chance. UBT251 is the treatment being tested and is not yet available for doctors to prescribe, while semaglutide is a medicine used to treat type 2 diabetes that doctors can already prescribe.
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereBirmingham, Alabama, United States + 68 more
SponsorNovo Nordisk A/S
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight
NCT07589608 · Overweight, Obesity
RecruitingThe main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to examine the body weight-lowering efficacy and safety of macupatide plus eloralintide compared with placebo in participants with obesity or overweight and without type 2 diabetes. Participation will last about 64 weeks.
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereChandler, Arizona, United States + 39 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
NCT07533175 · Diabetes Mellitus, Overweight, Obesity
RecruitingThe purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 73 more
SponsorNovo Nordisk A/S
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
NCT06112418 · Diabetes Mellitus, Type 2, PreDiabetes, Metabolic Syndrome
RecruitingTRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.
PhaseNA
TypeInterventional
Age55 Years
WhereChandler, Arizona, United States + 124 more
SponsorCleerly, Inc.
▾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
WhereHuntsville, Alabama, United States + 56 more
SponsorRegeneron Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Registry for Stage 2 Type 1 Diabetes
RecruitingStage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin. TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D. The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.
Phase—
TypeObservational
AgeAny
WhereLos Angeles, California, United States + 36 more
SponsorSanofi
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System
RecruitingThis multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.
PhaseNA
TypeInterventional
Age14 Years – 75 Years
WhereLos Angeles, California, United States + 11 more
SponsorInsulet Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
NCT07351045 · Obesity or Overweight
RecruitingThe purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAnniston, Alabama, United States + 163 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
NCT07351058 · Obesity or Overweight,
Type 2 Diabetes Mellitus RecruitingThe purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).
PhasePhase 3
TypeInterventional
Age18 Years
WhereGuntersville, Alabama, United States + 162 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts