Anorexia Nervosa in RemissionNCT06000774
Therapeutic Ketogenic Diet in Anorexia Nervosa
A study testing Therapeutic Ketogenic Diet in people with Anorexia Nervosa in Remission and Bulimia Nervosa, run by University of California, San Diego at 1 site in United States.
Trial summary
This study will investigate the effects of therapeutic ketogenic diet (TKD) on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa who have been weight normalized (body mass index of 17.5 or greater) but continue to struggle with eating disorder… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anorexia Nervosa in Remission, Bulimia Nervosa, Anorexia Nervosa
- What is being tested?
- Therapeutic Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Weight-Recovered AN Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons, aged 18 to 45 years
- History of anorexia nervosa according to DSM-5 criteria
- Weight recovered at the time of study inclusion (body mass index > 17.5 kg/m2)
- Greater or equal to 2 standard deviations scores of eating disorder-relevant behaviors on the Eating Disorder Inventory-3 and Eating Disorder Examination Questionnaire
- The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers
- English is primary spoken language
Weight-Recovered AN Exclusion Criteria:
- Pregnancy or lactation
- Electrolyte, blood count, kidney function or liver function abnormalities
- Psychosis
- Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
- Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
- Uncontrolled hypertension
- Hepatic impairment (Class-Pugh b or c)
- Diabetes mellitus
- Family history of porphyria
- History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
- Inability or unwillingness to adhere to the TKD diet for the duration of the study
- Blind or illiterate individuals
Underweight AN Sub-Study Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons, aged 18 to 45 years
- Anorexia nervosa according to DSM-5 criteria
- Current Body Mass Index (BMI) at the time of study inclusion of 16.0 to 17.49
- An elevated EDE-Q global score of 2.09 or greater
- The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers
- English is primary spoken language
Underweight AN Sub-Study Exclusion Criteria:
- Pregnancy or lactation
- Electrolyte, blood count, kidney function or liver function abnormalities
- Psychosis
- Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
- Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
- Uncontrolled hypertension
- Hepatic impairment (Class-Pugh b or c)
- Diabetes mellitus
- Family history of porphyria
- History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
- Inability or unwillingness to adhere to the TKD diet for the duration of the study
- Blind or illiterate individuals
Bulimia Nervosa Pilot Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons, aged 18 to 45 years
- History of bulimia nervosa according to DSM-5 criteria
- An elevated EDE-Q global score of 2.09 or greater
- The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers
- English is primary spoken language
Bulimia Nervosa Pilot Exclusion Criteria:
- Pregnancy or lactation
- Electrolyte, blood count, kidney function or liver function abnormalities
- Psychosis
- Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
- Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
- Uncontrolled hypertension
- Hepatic impairment (Class-Pugh b or c)
- Diabetes mellitus
- Family history of porphyria
- History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
- Inability or unwillingness to adhere to the TKD diet for the duration of the study
- Blind or illiterate individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
San Diego, California, 92121
Megan E Shott, BS, 858-246-5272, mshott@health.ucsd.edu
Guido Frank, MD, gfrank@health.ucsd.edu
About this study
Official title: Ketogenic Diet in Eating Disorders to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology
This study will investigate the effects of therapeutic ketogenic diet (TKD) on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa who have been weight normalized (body mass index of 17.5 or greater) but continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction.
The Underweight Anorexia Nervosa (AN) Sub-Study will investigate the effects of TKD on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa who are currently underweight (body mass index between 16.0 and 17.49) and continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction.
The Bulimia Nervosa Pilot will will investigate the effects of TKD on eating behavior including drive to binge and purge, body dissatisfaction, mood and anxiety in individuals with bulimia nervosa.
Read the detailed description
For this 14-week study, the investigator will recruit twenty individuals with anorexia nervosa who have been weight normalized but continue to have high impairment from the illness with a high (2 standard deviations above average) drive for thinness and body dissatisfaction and a high drive for food restriction and thus are at high risk for full relapse. Study participants will be carefully assessed and oriented to the ketogenic diet according to the procedures in our small previous trial (Calabrese, et al., 2022). The study will be conducted in a university medical environment, showing feasibility and safety in a typical medical setting. A commercial supplier will provide the ketogenic diet. After ketosis induction over two weeks, study participants will be assessed weekly for ketosis and mood, anxiety, and eating disorder symptoms.
For the BN Pillot study we will also complete a small pilot in 5 individuals with bulimia nervosa.
For the Underweight Anorexia Nervosa (AN) Sub-Study we will also recruit 30 individuals with anorexia nervosa who are mild to moderately underweight and have a body mass index of between 16.0 to 17.49.
Primary Objective 1 is to test the effects of ketogenic diet in individuals with anorexia nervosa who are weight recovered but continue to suffer severely from drive for thinness and are at very high relapse risk. Participants will be evaluated for tolerability of the study and weight trajectory. Primary Objective 2 is to assess improvement in AN symptoms and behaviors in relation to the ketogenic diet over a 12-week course. Participants will be assessed for specific symptoms such as drive for thinness and body dissatisfaction, fear of eating and weight gain. Primary Objective 3 is to assess the underlying genetic basis for the treatment effect of the ketogenic diet.
Bulimia Nervosa Pilot Objective 1: To test the effects of ketogenic diet in individuals with bulimia nervosa.
Bulimia Nervosa Pilot Objective 2: To assess improvement in BN symptoms and behaviors in relation to the ketogenic diet over a 2-week induction period followed by a 12-week course of the intervention. We expect especially a reduction in binge eating episodes and associated purging episodes in response to the treatment and in addition to improvement of the cognitive emotional symptoms.
Underweight AN Sub-Study Objective 1: To test the effects of ketogenic diet in individuals with anorexia nervosa who are currently mildly underweight and assess how the intervention impacts weight normalization in this population.
Underweight AN Sub-Study Objective 2: To assess improvement in AN symptoms and behaviors in relation to the ketogenic diet over a 2-week induction period followed by a 12-week course of the intervention.
Underweight AN Sub-Study Objective 3: To assess the underlying genetic basis for the treatment effect of the ketogenic diet.
- Being tested
- Therapeutic Ketogenic Diet
- Medical subject headings
- Bulimia Nervosa, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Ketogenic DietOther
therapeutic ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Ketogenic Diet | Experimental | A 2-week therapeutic ketogenic diet (TKD) induction will be implemented to establish nutritional ketosis (the goal are BHB blood levels of 0.5-3.0 millimoles per liter [mmol/L]). After establishing the ketotic state, study participants will continue TKD for 12 weeks. Receives: Other: Therapeutic Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered, individuals with anorexia nervosa who are currently underweight, and individuals with bulimia nervosa using weekly body weight measurements.
Weekly weights will be obtained to assess whether subjects remain within a normal weight range.
Measured: Weekly for the duration of the study intervention (14 weeks)
To assess the safety and tolerability in individuals with anorexia nervosa (AN) who are weight recovered, AN individuals who are currently underweight, and Bulimia Nervosa individuals using the Committee of Clinical Investigations UKU-Side Effect Scale
The UKU assesses psychiatric, neurologic, autonomic, and other side effects.
Measured: At weeks 4, 8, 12, 14
Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Global Score, EDEQ Eating Restraint Score, and EDEQ Weight Concern
The Eating Disorders Examination Questionnaire a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and weekly throughout the 14-week intervention and the investigator will measure the change in scores. The EDE Global, Eating Restraint, and Weight Concern scales have a range of 0 to 6 where higher scores mean worse outcome.
Measured: At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up
Measurement of the relationship between genotype and improvement of eating disorder symptoms
In order to identify potential genetic signatures that may predict response to treatment, Whole Exome Sequencing will be conducted on participants.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start3 Oct 2023
- Primary completionJun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anorexia Nervosa in RemissionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will complete a 14-week therapeutic ketogenic diet (TKD)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Frank, University of California, San Diego
- Investigators
- Guido Frank, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000774
- Sponsor's protocol ID
- 807674
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scolnick B, Zupec-Kania B, Calabrese L, Aoki C, Hildebrandt T. Remission from Chronic Anorexia Nervosa With Ketogenic Diet and Ketamine: Case Report. Front Psychiatry. 2020 Jul 30;11:763. doi: 10.3389/fpsyt.2020.00763. eCollection 2020.
PubMed 32848935Frank GKW, Shott ME, DeGuzman MC. The Neurobiology of Eating Disorders. Child Adolesc Psychiatr Clin N Am. 2019 Oct;28(4):629-640. doi: 10.1016/j.chc.2019.05.007. Epub 2019 Jul 4.
PubMed 31443880Frank GKW, Shott ME, Stoddard J, Swindle S, Pryor TL. Association of Brain Reward Response With Body Mass Index and Ventral Striatal-Hypothalamic Circuitry Among Young Women With Eating Disorders. JAMA Psychiatry. 2021 Oct 1;78(10):1123-1133. doi: 10.1001/jamapsychiatry.2021.1580.
PubMed 34190963Dignon A, Beardsmore A, Spain S, Kuan A. 'Why I won't eat': patient testimony from 15 anorexics concerning the causes of their disorder. J Health Psychol. 2006 Nov;11(6):942-56. doi: 10.1177/1359105306069097.
PubMed 17035265Calabrese L, Scolnick B, Zupec-Kania B, Beckwith C, Costello K, Frank GKW. Ketogenic diet and ketamine infusion treatment to target chronic persistent eating disorder psychopathology in anorexia nervosa: a pilot study. Eat Weight Disord. 2022 Dec;27(8):3751-3757. doi: 10.1007/s40519-022-01455-x. Epub 2022 Aug 23.
PubMed 35997954Frank GKW, Scolnick B, Beckwith C, Shott ME, Kilty S, Swindle S, Lutter M, Rho JM. Symptom impact and safety of ketogenic therapy in adults with anorexia nervosa: a feasibility trial. Commun Med (Lond). 2026 Jun 3;6(1):315. doi: 10.1038/s43856-026-01644-0.
PubMed 42236862
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Diet in Eating Disorders to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology
- ClinicalTrials.gov ID
- NCT06000774
- Acronym / sponsor ID
- 807674
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the effects of therapeutic ketogenic diet (TKD) on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa who have been weight normalized (body mass index of 17.5 or greater) but continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction.
The Underweight Anorexia Nervosa (AN) Sub-Study will investigate the effects of TKD on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa who are currently underweight (body mass index between 16.0 and 17.49) and continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction.
The Bulimia Nervosa Pilot will will investigate the effects of TKD on eating behavior including drive to binge and purge, body dissatisfaction, mood and anxiety in individuals with bulimia nervosa.
Detailed description
For this 14-week study, the investigator will recruit twenty individuals with anorexia nervosa who have been weight normalized but continue to have high impairment from the illness with a high (2 standard deviations above average) drive for thinness and body dissatisfaction and a high drive for food restriction and thus are at high risk for full relapse. Study participants will be carefully assessed and oriented to the ketogenic diet according to the procedures in our small previous trial (Calabrese, et al., 2022). The study will be conducted in a university medical environment, showing feasibility and safety in a typical medical setting. A commercial supplier will provide the ketogenic diet. After ketosis induction over two weeks, study participants will be assessed weekly for ketosis and mood, anxiety, and eating disorder symptoms.
For the BN Pillot study we will also complete a small pilot in 5 individuals with bulimia nervosa.
For the Underweight Anorexia Nervosa (AN) Sub-Study we will also recruit 30 individuals with anorexia nervosa who are mild to moderately underweight and have a body mass index of between 16.0 to 17.49.
Primary Objective 1 is to test the effects of ketogenic diet in individuals with anorexia nervosa who are weight recovered but continue to suffer severely from drive for thinness and are at very high relapse risk. Participants will be evaluated for tolerability of the study and weight trajectory. Primary Objective 2 is to assess improvement in AN symptoms and behaviors in relation to the ketogenic diet over a 12-week course. Participants will be assessed for specific symptoms such as drive for thinness and body dissatisfaction, fear of eating and weight gain. Primary Objective 3 is to assess the underlying genetic basis for the treatment effect of the ketogenic diet.
Bulimia Nervosa Pilot Objective 1: To test the effects of ketogenic diet in individuals with bulimia nervosa.
Bulimia Nervosa Pilot Objective 2: To assess improvement in BN symptoms and behaviors in relation to the ketogenic diet over a 2-week induction period followed by a 12-week course of the intervention. We expect especially a reduction in binge eating episodes and associated purging episodes in response to the treatment and in addition to improvement of the cognitive emotional symptoms.
Underweight AN Sub-Study Objective 1: To test the effects of ketogenic diet in individuals with anorexia nervosa who are currently mildly underweight and assess how the intervention impacts weight normalization in this population.
Underweight AN Sub-Study Objective 2: To assess improvement in AN symptoms and behaviors in relation to the ketogenic diet over a 2-week induction period followed by a 12-week course of the intervention.
Underweight AN Sub-Study Objective 3: To assess the underlying genetic basis for the treatment effect of the ketogenic diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will complete a 14-week therapeutic ketogenic diet (TKD)
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Ketogenic Diet | Experimental | Other: Therapeutic Ketogenic DietA 2-week therapeutic ketogenic diet (TKD) induction will be implemented to establish nutritional ketosis (the goal are BHB blood levels of 0.5-3.0 millimoles per liter [mmol/L]). After establishing the ketotic state, study participants will continue TKD for 12 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Ketogenic Diettherapeutic ketogenic diet | Other | Therapeutic Ketogenic Diet |
Primary outcome
To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered, individuals with anorexia nervosa who are currently underweight, and individuals with bulimia nervosa using weekly body weight measurements.
Time frame: Weekly for the duration of the study intervention (14 weeks)
Weekly weights will be obtained to assess whether subjects remain within a normal weight range.
To assess the safety and tolerability in individuals with anorexia nervosa (AN) who are weight recovered, AN individuals who are currently underweight, and Bulimia Nervosa individuals using the Committee of Clinical Investigations UKU-Side Effect Scale
Time frame: At weeks 4, 8, 12, 14
The UKU assesses psychiatric, neurologic, autonomic, and other side effects.
Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Global Score, EDEQ Eating Restraint Score, and EDEQ Weight Concern
Time frame: At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up
The Eating Disorders Examination Questionnaire a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and weekly throughout the 14-week intervention and the investigator will measure the change in scores. The EDE Global, Eating Restraint, and Weight Concern scales have a range of 0 to 6 where higher scores mean worse outcome.
Measurement of the relationship between genotype and improvement of eating disorder symptoms
Time frame: At baseline
In order to identify potential genetic signatures that may predict response to treatment, Whole Exome Sequencing will be conducted on participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 32848935Scolnick B, Zupec-Kania B, Calabrese L, Aoki C, Hildebrandt T. Remission from Chronic Anorexia Nervosa With Ketogenic Diet and Ketamine: Case Report. Front Psychiatry. 2020 Jul 30;11:763. doi: 10.3389/fpsyt.2020.00763. eCollection 2020.
- Background: PubMed 31443880Frank GKW, Shott ME, DeGuzman MC. The Neurobiology of Eating Disorders. Child Adolesc Psychiatr Clin N Am. 2019 Oct;28(4):629-640. doi: 10.1016/j.chc.2019.05.007. Epub 2019 Jul 4.
- Background: PubMed 34190963Frank GKW, Shott ME, Stoddard J, Swindle S, Pryor TL. Association of Brain Reward Response With Body Mass Index and Ventral Striatal-Hypothalamic Circuitry Among Young Women With Eating Disorders. JAMA Psychiatry. 2021 Oct 1;78(10):1123-1133. doi: 10.1001/jamapsychiatry.2021.1580.
- Background: PubMed 17035265Dignon A, Beardsmore A, Spain S, Kuan A. 'Why I won't eat': patient testimony from 15 anorexics concerning the causes of their disorder. J Health Psychol. 2006 Nov;11(6):942-56. doi: 10.1177/1359105306069097.
- Background: PubMed 35997954Calabrese L, Scolnick B, Zupec-Kania B, Beckwith C, Costello K, Frank GKW. Ketogenic diet and ketamine infusion treatment to target chronic persistent eating disorder psychopathology in anorexia nervosa: a pilot study. Eat Weight Disord. 2022 Dec;27(8):3751-3757. doi: 10.1007/s40519-022-01455-x. Epub 2022 Aug 23.
- Derived from this study: PubMed 42236862Frank GKW, Scolnick B, Beckwith C, Shott ME, Kilty S, Swindle S, Lutter M, Rho JM. Symptom impact and safety of ketogenic therapy in adults with anorexia nervosa: a feasibility trial. Commun Med (Lond). 2026 Jun 3;6(1):315. doi: 10.1038/s43856-026-01644-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guido Frank, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Ketogenic Diet in people with Anorexia Nervosa in Remission and Bulimia Nervosa, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Shott, BS (848-246-5272, mshott@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered, individuals with anorexia nervosa who are currently underweight, and individuals with bulimia nervosa using weekly body weight measurements. (time frame: Weekly for the duration of the study intervention (14 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06000774, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.