8 completed, 8 recruiting, 8 unknown, 3 not yet recruiting. 33 Phase 2, 7 Phase 3, 4 Phase 1.
Follow Ketosis: new trials by email Literature Review of Ketosis trials Research Report on Ketosis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring. Sotagliflozin initiation - Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM) | Phase 2 | Not yet recruiting | HealthPartners Institute | 80 | 2027-01-01 | 2026-10-23 |
| Effects of Ketones on Brain Energetics and Alcohol Consumption in Alcohol Use Disorder Kenetik, magnetic resonance imaging scan, Alcohol bar lab - Alcohol Use Disorder, Ketosis | Phase 2 / Phase 3 | Recruiting | University of Pennsylvania | 60 | 2026-12-01 | 2026-10-21 |
| Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes PAL-119, Placebo - Healthy Volunteers and Diabetes Participants | Phase 1 / Phase 2 | Not yet recruiting | Paulex Bio Inc. | 147 | 2026-11-01 | 2026-10-28 |
| Ketones for Opioid Craving Treatment with Ketone Supplement, Treatment with Placebo - Opioid Use Disorder | Phase 2 | Recruiting | University of Maryland, Baltimore | 50 | 2026-07-16 | 2026-08-25 |
| Exogenous Ketone Supplementation in ICU Delirium Ketone monoester, Placebo - ICU Delirium, Critical Illness | Phase 2 | Recruiting | Vanderbilt University Medical Center | 40 | 2026-06-09 | 2026-08-24 |
| Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes CIR-0602K, Placebo - Type 1 Diabetes (T1D), Glycemic Control for Diabetes Mellitus | Phase 2 | Recruiting | University of Virginia | 40 | 2026-02-22 | 2026-02-25 |
| Evaluating Safe Ketone Thresholds To Minimise Ketosis in People With Type 1 Diabetes Using Dapagliflozin FORXIGA - Type 1 Diabetes Mellitus | Phase 2 | Not yet recruiting | St Vincent's Hospital Melbourne | 115 | 2026-02-01 | 2025-11-06 |
| Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes Arginine hydrochloride, Sodium Chloride 0.9% - Diabetes (DM), Diabetic Ketoacidosis | Phase 1 / Phase 2 | Recruiting | David K Carroll | 60 | 2025-12-19 | 2026-02-12 |
| Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones,, magnetic resonance imaging session, Placebo beverage - Alcohol Use Disorder, Alcohol Withdrawal | Phase 2 / Phase 3 | Recruiting | University of Pennsylvania | 30 | 2025-08-01 | 2026-11-05 |
| Chronic Exogenous Ketosis in HFpEF Exogenous Ketone Drink, Placebo - Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Normal Ejection Fraction | Phase 2 | Enrolling by invitation | Duke University | 20 | 2025-07-28 | 2026-10-14 |
| Effects of Ketone Supplement and Alcohol on Brain Metabolism Kenetik, Alcohol beverage - Ketosis, Alcohol Drinking | Phase 2 / Phase 3 | Active not recruiting | University of Pennsylvania | 60 | 2025-05-13 | 2026-10-14 |
| REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis Reamberin, Placebo - Diabetic Ketoacidosis | Phase 2 / Phase 3 | Recruiting | POLYSAN Scientific & Technological Pharmaceutical Company | 312 | 2025-05-01 | 2025-06-24 |
| Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure 1,3-butanediol, Placebo - Acute Heart Failure (AHF) | Phase 2 | Recruiting | Aarhus University Hospital | 250 | 2025-03-20 | 2025-06-05 |
| Impact of Exogenous Ketones on Sleep Apnea Ketone-IQ, Placebo - Obstructive Sleep Apnea, Sleep | Phase 1 / Phase 2 | Withdrawn | Johns Hopkins University | 2025-01-29 | 2026-09-21 | |
| Effects of Ketone Supplementation on Acute Alcohol Withdrawal Kenetik; Ketone Concentrate, Isocaloric dextrose placebo - Alcohol Use Disorder, Alcohol Withdrawal | Phase 2 / Phase 3 | Enrolling by invitation | University of Pennsylvania | 50 | 2024-03-11 | 2026-04-06 |
| Ketones in Heart Failure With Reduced Ejection Fraction ketone ester, placebo - Heart Failure With Reduced Ejection Fraction | Phase 2 | Completed | Duke University | 25 | 2024-03-06 | 2026-09-03 |
| Effect of Nutritional Ketosis on Alcohol Metabolism Ketone Supplement, Control Diet, Ketogenic diet - Ketoses, Metabolic, Ketogenic Dieting | Phase 2 / Phase 3 | Active not recruiting | University of Pennsylvania | 23 | 2024-02-29 | 2026-04-07 |
| Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise Ketone ester, Placebo, Exercise - Sleep | Phase 2 | Unknown | KU Leuven | 11 | 2022-05-15 | 2022-06-30 |
| Concurrent Subcutaneous Basal Insulin and Intravenous Insulin Pump in Hyperglycemic Crisis Patients Under Critical Care Insulin Glargine 300 UNT/ML [Toujeo] - Hyperglycaemic Crisis in Diabetes Mellitus, Diabetic Ketoacidosis | Phase 2 | Unknown | Changhua Christian Hospital | 70 | 2022-03-01 | 2022-03-10 |
| Ketone Administration During Inactivity and Retraining Ketone ester, Medium Chain Triglyceride (MCT) oil - Exercise, Healthy Male/Female Subjects | Phase 2 | Unknown | KU Leuven | 24 | 2021-12-15 | 2022-05-31 |
Showing 20 of 33. Sign in to see all of them.
Diabetic Ketoacidosis (7) · Diabetes Mellitus, Type 1 (5) · Motor Activity (5) · Heart Failure (4) · Alcoholism (3) · Alcohol Drinking (2) · Alzheimer Disease (2) · Heart Failure, Systolic (2) · Acidosis (1) · Alcoholic Intoxication (1) · Breast Neoplasms (1) · Bronchiolitis Obliterans Syndrome (1) · Critical Illness (1) · Diabetes Mellitus (1)
Acid-Base Imbalance (33) · Metabolic Diseases (33) · Nutritional and Metabolic Diseases (33) · Acidosis (32) · Endocrine System Diseases (9) · Cardiovascular Diseases (8) · Diabetes Mellitus (8) · Behavior (7) · Diabetes Complications (7) · Mental Disorders (7) · Heart Diseases (6) · Immune System Diseases (6) · Autoimmune Diseases (5) · Chemically-Induced Disorders (5)
formic acid 4-(3-oxobutyl)phenyl ester (4) · Ethanol (3) · Ketones (2) · Sodium Chloride (2) · tricaprylin (2) · (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (1) · 1,3-butylene glycol (1) · AC-1202 (1) · Alcoholic Beverages (1) · Arginine (1) · Diet (1) · Diet, Diabetic (1) · Diet, Ketogenic (1) · Diet, Sodium-Restricted (1) · Exercise (1)
University of Aarhus (5) · University of Pennsylvania (5) · KU Leuven (3) · Cerecin (2) · Duke University (2) · Aarhus University Hospital (1) · Beth Israel Deaconess Medical Center (1) · Burke Rehabilitation Hospital (1) · Changhua Christian Hospital (1) · David K Carroll (1) · HealthPartners Institute (1) · Johns Hopkins University (1) · MedSIR (1) · POLYSAN Scientific & Technological Pharmaceutical Company (1) · Paulex Bio Inc. (1)
United States (17) · Denmark (6) · Belgium (3) · Australia (1) · China (1) · Russia (1) · Spain (1) · Taiwan (1)
Corinde Wiers, Ph.D. (4) · Senthil Selvaraj, MD (2) · Antonio Llombart, MD (1) · Carolin I Dohle, MD (1) · Corinde E Wiers, Ph.D. (1) · Dalong Zhu, MD.PhD. (1) · E. Wes Ely, MD, MPH (1) · Henrik Wiggers, MD, PhD, DMSc (1) · Henry Kranzler, MD (1) · Jonathan Jun, MD (1) · Kieron D Rooney, MBBS (1) · Kristian H Christensen, MD (1) · Kristoffer Berg-Hansen, MD, PhD (1) · Kyle Kampman, MD (1) · Michael Donnino, MD (1)
PMID 17508198, PMID 19664276, PMID 21992747, PMID 22685233, PMID 25905280, PMID 31862758, PMID 35941696, PMID 37183871, PMID 37259248, PMID 37301762, PMID 38423765, PMID 40043832
R21AA031088 (2), K23HL161348 (1), R01AA031570 (1), R01DK112886 (1), R21AA031337 (1), U01DK143330 (1), U01DK143379 (1)