24 completed, 12 recruiting, 9 unknown, 6 terminated. 63 Phase 2, 14 Phase 3, 11 Phase 1.
Follow Acid-Base Imbalance: new trials by email Literature Review of Acid-Base Imbalance trials Research Report on Acid-Base Imbalance
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 |
|---|---|---|---|---|---|---|
| A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus) Glycerol Tributyrate - MELAS Syndrome, Lebers Hereditory Optic Neuropathy With Extra Ocular Symptoms (LHON-Plus) | Phase 1 / Phase 2 | Not yet recruiting | George Washington University | 24 | 2027-03-01 | 2026-10-05 |
| 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 |
| Adding Urea to the Final Dialysis Fluid Urea in the dialysate - Dysequilibrium Syndrome, ESRD | Phase 1 / Phase 2 | Recruiting | University of California, San Francisco | 20 | 2025-09-16 | 2026-02-12 |
| An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM) zagociguat 15mg - Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome) | Phase 2 | Terminated | Tisento Therapeutics | 37 | 2025-08-18 | 2026-11-06 |
| 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 | |
| A Phase 2b Study of Zagociguat in Patients With MELAS zagociguat 15mg, zagociguat 30mg, Placebo - Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome) | Phase 2 | Completed | Tisento Therapeutics | 43 | 2024-09-10 | 2026-10-23 |
| Bone in CKD Alkali Response (BICARb Pilot Trial) Potassium Citrate Extended Release Oral Tablet, Placebo, Potassium Citrate and Citric Acid Oral Solution - Chronic Kidney Diseases, Bone Loss | Phase 2 / Phase 3 | Terminated | Albert Einstein College of Medicine | 6 | 2024-08-15 | 2026-07-28 |
| 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 |
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Ketosis (27) · Acidosis, Lactic (14) · Acidosis (12) · Diabetic Ketoacidosis (7) · Renal Insufficiency, Chronic (6) · Diabetes Mellitus, Type 1 (5) · MELAS Syndrome (5) · Motor Activity (5) · Heart Failure (4) · Alcoholism (3) · Hemorrhage (3) · Metabolism, Inborn Errors (3) · Mitochondrial Diseases (3) · Mitochondrial encephalopathy (3)
Nutritional and Metabolic Diseases (63) · Metabolic Diseases (61) · Acidosis (48) · Pathological Conditions, Signs and Symptoms (23) · Pathologic Processes (17) · Cardiovascular Diseases (15) · Nervous System Diseases (13) · Brain Diseases (11) · Central Nervous System Diseases (11) · Disease Attributes (11) · Endocrine System Diseases (10) · Signs and Symptoms (10) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (9) · Heart Diseases (9)
Sodium Chloride (5) · Saline Solution (4) · Sodium Bicarbonate (4) · formic acid 4-(3-oxobutyl)phenyl ester (4) · Ethanol (3) · PEG-hemoglobin (3) · Thiamine (3) · maleimide-polyethylene glycol-modified hemoglobin, MP4 (3) · Dichloroacetic Acid (2) · Ketones (2) · Oxygen (2) · Potassium Chloride (2) · Potassium Citrate (2) · Reamberin (2) · polynitroxylated pegylated hemoglobin (2)
University of Aarhus (5) · University of Pennsylvania (5) · Albert Einstein College of Medicine (3) · KU Leuven (3) · Sangart (3) · Beth Israel Deaconess Medical Center (2) · Cerecin (2) · Duke University (2) · ModernaTX, Inc. (2) · POLYSAN Scientific & Technological Pharmaceutical Company (2) · Tisento Therapeutics (2) · Aarhus University Hospital (1) · Amgen (1) · Asan Medical Center (1) · Burke Rehabilitation Hospital (1)
United States (32) · United Kingdom (10) · Germany (7) · Denmark (6) · France (6) · Australia (5) · Belgium (4) · Canada (4) · Spain (4) · Brazil (3) · Italy (3) · Netherlands (3) · South Africa (3) · Switzerland (3) · Israel (2)
Corinde Wiers, Ph.D. (4) · Karim Brohi, MD (3) · Senthil Selvaraj, MD (2) · Thomas Hostetter, MD (2) · Anne Chiaramello, Ph.D. (1) · Antonio Llombart, MD (1) · Baback Roshanravan, MD (1) · Bruce Barshop (1) · Carolin I Dohle, MD (1) · Corinde E Wiers, Ph.D. (1) · Dalong Zhu, MD.PhD. (1) · Darryl C De Vivo, MD (1) · Debra Regier, M.D., Ph.D. (1) · Dileep Lobo, MBBS MD FRCS (1) · Donogh Maguire, MB BCh (1)
PMID 17508198, PMID 19183804, PMID 19664276, PMID 21992747, PMID 22580944, PMID 22685233, PMID 22773591, PMID 23393105, PMID 25905280, PMID 28606907, PMID 29102959, PMID 29850134, PMID 29866165, PMID 31699517, PMID 31862758, PMID 34784301, PMID 35484175, PMID 35941696, PMID 36577040, PMID 37183871, PMID 37259248, PMID 37301762, PMID 38423765, PMID 39665575, PMID 40043832, PMID 41433250
R21AA031088 (2), 2009 (1), 2015 (1), 2023 (1), K23HL128814 (1), K23HL161348 (1), R01AA031570 (1), R01DK087783 (1), R01DK112886 (1), R01DK129793 (1), R01DK131811 (1), R21AA031337 (1), U01DK143330 (1), U01DK143379 (1), UH3TR003897 (1)