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Taking people in United StatesPhase 2

Ketone Drink Tested for Liver Fat in Young Adults With Obesity

Tests a ketone ester drink against a placebo for liver fat in people with obesity.

Key facts

Who runs it
Washington University School of Medicine
Where
St Louis, United StatesSee the site
Trial code
Registry title
Effect of Ketone Esters on Liver Fat Content and Metabolic Function
Status
Recruiting
Phase
Phase 2
People taking part
40 people, planned
Started
26 Sept 2025
Expected to end
31 Dec 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • bis-octanoyl (R)-1,3-butanediol (C8 ketone di-ester)
  • Placebo
Record updated
15 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 40 with overweight or obesity and extra fat in the liver (MASLD). It tests a ketone ester drink against a placebo drink for 6 weeks.

Age
18 to 40 years
Sex
All sexes
Disease stage
BMI 25.0 to 49.9 kg/m2 and liver fat above 5% on an MRI scan (MRI-PDFF).
Earlier treatment
No bariatric surgery and no plan for it. Metformin is allowed only at a stable dose for at least 3 months without stomach or gut symptoms.
Biomarker or test result
Liver fat content above 5% measured by MRI-PDFF. Fibroscan CAP score must not be below 240 dB/m.

Main reasons for not taking part

  • HbA1C of 6.5% (48 mmol/mol) or higher
  • Liver disease other than MASLD, or cirrhosis
  • Organ transplant, or HIV with lipodystrophy
  • Pregnant or breastfeeding
  • Weight change of more than 3% in the last 2 months

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • Age: ≥18 and ≤40 years
  • BMI 25.0 - 49.9 kg/m2
  • Intrahepatic triglyceride content >5% assessed by using magnetic resonance imaging-proton density fat fraction (MRI-PDFF)

Who cannot take part

  • taking dietary supplements or medications known to affect our study outcomes including corticosteroids and other drugs associated with steatosis (metformin use will be allowable if participants have taken a stable dose for at least 3 months without any gastrointestinal-related symptoms)
  • Fibroscan controlled attenuation parameter (CAP) score <240 dB/m assessed within last 2 months before entering the study
  • consume tobacco products, excessive alcohol (females: >14 drinks/week; males: >21 drinks/week), or illegal drugs determined by medical history
  • have had bariatric surgery or plan to have endoscopic or bariatric surgery therapy for obesity
  • have undergone organ transplantation
  • metal implants that are not MRI-compatible
  • Unstable weight (>3% change during the last 2 months before entering the study)
  • active eating disorder, any anaphylactic food allergy and/or consuming a very-low-carbohydrate (<50 g/day) diet
  • recent (<2 months) history of moderate-severe nausea, vomiting, diarrhea, or other significant gastrointestinal symptoms
  • evidence of significant active organ system dysfunction, liver disease other than MASLD (e.g., Wilson disease, viral hepatitis, inborn errors of metabolism, or alpha-1 antitrypsin deficiency) or cirrhosis as a results of any condition or disease
  • have HIV and any other type of congenital or acquired lipodystrophy
  • major psychiatric illness
  • HbA1C ≥6.5%
  • Anemia (hemoglobin <10.5 g/dL in females and <11.0 g/dL in males)
  • pregnancy, as determined by a urine HCG screening test assessed performed at all screening, baseline testing, and follow-up visits. In addition, male and female participants of reproductive and childbearing age who wish to enroll will be required to agree to use contraception throughout the study period, and for 30 days after the last dose of C8 ketone di-ester
  • unwilling or unable to provide informed consent
  • female participants who are currently lactating
  • Structured exercise: ≥75 min/wk of vigorous exercise (e.g., jogging, activity that causes heavy breathing and sweating) or ≥200 min/wk of low intensity physical activity (e.g., brisk walking)
  • Unable or unwilling to follow the study protocol or who, for any reason, is considered an inappropriate candidate for the study by the research team

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 40 years old?

Where in United States

  • Washington University School of MedicineSt Louis, United StatesContact: Nikki Plassmeyer, RDN, LDTaking people

About the trial

What the trial wants to find out

The goal of this clinical trial is to determine whether ingestion of a ketone ester drink helps improve liver health and blood glucose control. Ketones are a type of energy source made by the body during times of weight loss, low carbohydrate intake and starvation.

Read full original descriptionShow less

People enrolled in this study will be randomly assigned (by chance, like the flip of a coin) to one of two groups:

Group 1: Ketone ester drink consumed daily for 6 weeks. Group 2: Placebo drink consumed daily for 6 weeks.

The 2 groups in the trial

  • PlaceboPlacebo, for comparison

    25 g Placebo per day for approximately 6-weeks

  • C8 ketone di-esterTreatment being tested

    25 g C8 ketone di-ester per day for approximately 6-weeks

    Treatment: bis-octanoyl (R)-1,3-butanediol (C8 ketone di-ester)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect of Ketone Esters on Liver Fat and Metabolic Function in Adolescents and Young Adults With Overweight/Obesity and MASLD
Plain-language title
Ketone Drink Tested for Liver Fat in Young Adults With ObesityGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07097506, who can take part
Record updated
15 July 2026