10 completed, 2 not yet recruiting, 2 terminated, 2 unknown. 20 Phase 1, 4 Phase 2.
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-SLEEP) KETONE-IQ 20 grams (g), KETONE-IQ 40 grams (g) - Healthy Participants, Sleep | Phase 1 | Completed | Johns Hopkins University | 20 | 2025-12-18 | 2026-09-28 |
| Investigating the Evolutionary Impact of Metabolic Flexibility on Physical Activity-Dependent BDNF and Cognition: Insights From the Val66Met Polymorphism d-beta-hydroxybutrate, Placebo - Cognition, BDNF | Phase 1 | Not yet recruiting | University of Southern California | 50 | 2025-11-01 | 2025-10-20 |
| Impact of Exogenous Ketones on Sleep Apnea Ketone-IQ, Placebo - Obstructive Sleep Apnea, Sleep | Phase 1 / Phase 2 | Withdrawn | Johns Hopkins University | 2025-01-29 | 2026-09-21 | |
| Impact of Exogenous Ketones on Sleep Disruption in Vulnerable Populations Ketone-IQ (1,3 Butanediol) - Obstructive Sleep Apnea, Sleep | Phase 1 | Suspended | Johns Hopkins University | 30 | 2025-01-29 | 2026-06-23 |
| Ketone Pharmacokinetic Study in HFrEF DeltaG (250 mg/kg), DeltaG (500 mg/kg) - Heart Failure With Reduced Ejection Fraction | Phase 1 | Completed | Duke University | 20 | 2023-06-02 | 2024-12-27 |
| Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers SGLT2 inhibitor, Controlled, Adaptive Study Diet - Ketones, Metabolism | Phase 1 | Active not recruiting | AdventHealth Translational Research Institute | 9 | 2023-03-16 | 2026-03-30 |
| Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D) Dapagliflozin, Placebo oral tablet, Stress - Type 1 Diabetes, Diabetic Ketoacidosis | Phase 1 | Terminated | Kinderkrankenhaus auf der Bult | 2 | 2022-05-18 | 2024-12-09 |
| Nutritional Ketosis in Heart Failure beta hydroxybutyrate (BHB) ester, Placebo - Chronic Heart Failure | Phase 1 | Unknown | Thomas Jefferson University | 16 | 2020-06-01 | 2020-05-01 |
| Sodium-glucose Co Transporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production empagliflozin (Jardiance) 25 mg - Empaglifozin, Physiological Effects of Drugs | Phase 1 | Completed | National Institute on Aging (NIA) | 21 | 2019-03-28 | 2022-08-02 |
| Effects of Ketone Bodies on Cognition in Type 2 Diabetes Ketone infusion, Saline infusion - Type2 Diabetes, Ketonemia | Phase 1 | Completed | Bispebjerg Hospital | 18 | 2018-09-17 | 2019-02-20 |
| Exogenous Ketones and Glucose Tolerance Ketone monoester, Placebo - Ketones, Dietary Supplements | Phase 1 | Completed | University of British Columbia | 15 | 2018-03-26 | 2019-04-18 |
| Treatment of Recurrent Brain Tumors: Metabolic Manipulation Combined With Radiotherapy Partial brain re-irradiation., Metformin, low carbohydrate diet - Brain Neoplasms | Phase 1 | Unknown | Sheba Medical Center | 18 | 2014-06-01 | 2017-10-27 |
| Effects of a Ketogenic Diet on Acute Stroke Ketocal 4:1 (Nutricia), Control diet: Regular diet offered at the hospitals, Ketogenic meals - Acute Stroke | Phase 1 | Completed | University of Copenhagen | 64 | 2013-05-01 | 2014-07-18 |
| Effects of Triglycerides on Age-Related Cognitive Function Decline in Older Subjects GSK2981710, Placebo - Alzheimer's Disease | Phase 1 | Completed | GlaxoSmithKline | 116 | 2012-11-05 | 2017-05-09 |
| Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation Modified Atkins Diet, Control diet - Stroke, Ischemic Stroke | Phase 1 / Phase 2 | Completed | Burke Rehabilitation Hospital | 20 | 2012-03-01 | 2016-02-24 |
| Pilot Study of the Modified Atkins Diet for Tourette Syndrome Modified Atkins diet - Tourette Syndrome | Phase 1 | Terminated | Johns Hopkins University | 20 | 2008-09-01 | 2010-07-15 |
| Atkins Diet for Difficult-to-Control Headaches in Teenagers Modified Atkins diet - Chronic Daily Headache | Phase 1 | Completed | Johns Hopkins University | 10 | 2005-09-01 | 2009-07-02 |
| Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits Modified Atkins diet - Epilepsy | Phase 1 | Completed | Johns Hopkins University | 30 | 2005-02-01 | 2009-03-27 |
Diabetes Mellitus, Type 1 (3) · Diabetic Ketoacidosis (3) · Alzheimer Disease (2) · Diabetes Mellitus (2) · Hyperglycemia (2) · Insulin Resistance (2) · Sleep Apnea Syndromes (2) · Sleep Apnea, Obstructive (2) · Stroke (2) · Astrocytoma (1) · Brain Neoplasms (1) · Diabetes Mellitus, Type 2 (1) · Epilepsy (1) · Glioblastoma (1)
Acid-Base Imbalance (20) · Acidosis (20) · Metabolic Diseases (20) · Nutritional and Metabolic Diseases (20) · Nervous System Diseases (10) · Brain Diseases (8) · Central Nervous System Diseases (8) · Glucose Metabolism Disorders (6) · Endocrine System Diseases (4) · Pathological Conditions, Signs and Symptoms (4) · Autoimmune Diseases (3) · Diabetes Complications (3) · Immune System Diseases (3) · Mental Disorders (3)
1,3-butylene glycol (1) · 3-Hydroxybutyric Acid (1) · Arginine (1) · Biguanides (1) · Control Groups (1) · Diet (1) · Diet, Carbohydrate-Restricted (1) · Diet, Diabetic (1) · Diet, Sodium-Restricted (1) · Esters (1) · GSK2981710 (1) · Hypoglycemic Agents (1) · Metformin (1) · Radiotherapy (1) · Saline Solution (1)
Johns Hopkins University (6) · AdventHealth Translational Research Institute (1) · Bispebjerg Hospital (1) · Burke Rehabilitation Hospital (1) · David K Carroll (1) · Duke University (1) · GlaxoSmithKline (1) · Kinderkrankenhaus auf der Bult (1) · National Institute on Aging (NIA) (1) · Paulex Bio Inc. (1) · Sheba Medical Center (1) · Thomas Jefferson University (1) · University of British Columbia (1) · University of Copenhagen (1) · University of Southern California (1)
United States (12) · Denmark (2) · Canada (1) · Germany (1) · Israel (1) · United Kingdom (1)
Jonathan Jun, MD (3) · Eric H Kossoff, MD (2) · Carolin I Dohle, MD (1) · J. Eduardo Rame, M.D. (1) · Jens Rikardt Andersen, MD (1) · Josephine M Egan, M.D. (1) · Melissa Erickson, PhD (1) · Senthil Selvaraj, MD, MSTR, MA (1) · Torben Biester, MD (1) · Yaacov R Lawrence, MA MBBS MRCP (1)
K23HL161348 (1)