Effect of Ketone Esters on Liver Fat Content and Metabolic Function

NCT07097506 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 202503064
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Obesity; Overweight (BMI > 25)

Outcome Measures

Primary Outcomes (2)

• Change in Intrahepatic triglyceride content

  Intrahepatic triglyceride content will be assessed by magnetic resonance imagining (MRI)

  Before and at the end of treatment at 6-weeks

• Change in insulin sensitivity

  Whole-body insulin sensitivity will be assessed by using the hyperinsulinemic-euglycemic clamp procedure

  Before and at the end of treatment at 6-weeks

Secondary Outcomes (2)

• Change in β-cell function

  Before and at the end of treatment at 6-weeks

• Change in glycemic control

  Before and at the end of treatment at 6-weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

25 g Placebo per day for approximately 6-weeks

Other: Placebo

C8 ketone di-ester

EXPERIMENTAL

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

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

Interventions

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

25 g C8 ketone di-ester taken daily for approximately 6-weeks

Also known as: Qitone

C8 ketone di-ester

Placebo OTHER

25 g Placebo taken daily for approximately 6-weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: ≥18 and ≤25 years;
• BMI 25.0 - 44.9 kg/m2;
• Intrahepatic triglyceride content \>5% assessed by using magnetic resonance imaging-proton density fat fraction (MRI-PDFF).

You may not qualify if:

• HbA1C ≥6.5%;
• 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);
• active eating disorder, any anaphylactic food allergy and/or consuming a very-low-carbohydrate (\<50 g/day) diet;
• Fibroscan controlled attenuation parameter (CAP) score \<240 dB/m assessed within last 2 months before entering the study;
• recent (\<2 months) history of moderate-severe nausea, vomiting, diarrhea, or other significant gastrointestinal symptoms;
• consume tobacco products, excessive alcohol (females: \>14 drinks/week; males: \>21 drinks/week), or illegal drugs determined by medical history;
• 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 had bariatric surgery or plan to have endoscopic or bariatric surgery therapy for obesity;
• have undergone organ transplantation;
• have HIV and any other type of congenital or acquired lipodystrophy;
• unwilling or unable to provide informed consent;
• major psychiatric illness;
• metal implants that are not MRI-compatible;
• 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;
• female participants who are currently lactating;

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Children's Discovery Institute: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Klein, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikki Plassmeyer, RDN, LD

CONTACT

314-362-0590; nikkip@wustl.edu

Central contact information

CONTACT

314-273-1879; nutritionresearch@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, placebo controlled study design

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: September 26, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)