Bipolar DisorderPhase 4MOBILITYNCT02515773

Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs

A Phase 4 study testing Metformin and healthy lifestyle intervention (LIFE) in people with Bipolar Disorder, run by Melissa Delbello at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A prospective, large, pragmatic, randomized trial to study the impact of METFORMIN and healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood/anxiety), and Quality of Life. Read more about this study

Who is it for?: Ages 8 to 19 years
Conditions the study is for: Bipolar Disorder
What is being tested?: Metformin and healthy lifestyle intervention (LIFE)
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,565 participants
Where: 29 sitesUnited States
Study dates: Dec 2015to Jun 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 8 to 19 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Inpatient or outpatient age 8-19 years inclusive; participants must live with a parent, guardian, or caregiver;
Fluent in English;
Diagnosed or told by a clinician that they have any of the following bipolar spectrum disorders (BSD): bipolar I, bipolar II, unspecified bipolar and related disorders, Disruptive Mood Dysregulation Disorder (DMDD), cyclothymic disorder, other specified bipolar and related disorders, as well as mood disorder not otherwise specified (if diagnosed in the past as per DSM-IV);
Body mass index >85%ile for age and sex by standard growth charts;
Received a new or ongoing prescription for at least one SGA (i.e., olanzapine, clozapine, risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone, brexpiprazole or cariprazine) that is not prescribed as a PRN medication;

Who cannot join

Patients will be excluded if they have had exposure to a total daily dose of MET 1000 mg bid for at least 2 weeks in the past 3 months;
Patients will be excluded if they could not tolerate MET during the recommended titration schedule outlined in the protocol;
Major neurological or medical illnesses that affect weight gain (e.g., unstable thyroid disease) or require a systemic medication that might impact weight or glucose regulation (e.g., diabetes mellitus [insulin], chronic renal failure [steroids]);
Fasting glucose ≥ 126 mg/dL on 2 occasions during screening indicating need for prompt treatment;
If lab results are available in the last 6 months, then a serum creatinine ≥1.3 mg/dL on 2 occasions during screening and/or follow-up, indicating potential impairment of renal functioning;
Pregnant or breast feeding;
Children and caregivers who are unable to complete assessments for any reason;

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

United States29 sites

South Oaks
Amityville, New York, 11701
Seton Family of Hospitals
Austin, Texas, 78712
SUNY Downstate/ Kings County Hospital
Brooklyn, New York, 11203
Maimonides
Brooklyn, New York, 11219
NYCCC
Brooklyn, New York, 11233
Lighthouse Youth Services
Cincinnati, Ohio, 45206
Central Clinic
Cincinnati, Ohio, 45219
Children's Home
Cincinnati, Ohio, 45227
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Resident Mood Medication Clinic
Cincinnati, Ohio, 45229
St. Aloysius
Cincinnati, Ohio, 45237
Talbert House
Cincinnati, Ohio, 45238
St. Joseph's Orphanage
Cincinnati, Ohio, 45239
Child Focus
Cincinnati, Ohio, 45244
NECCO
Cincinnati, Ohio, 45246
University Hospital Medical Center Cleveland
Cleveland, Ohio, 44106
Nationwide Children's Hospital Columbus
Columbus, Ohio, 43205
Ohio State University
Columbus, Ohio, 43210
The Children's Home of Northern Kentucky
Covington, Kentucky, 41011
South Community
Dayton, Ohio
Northwell Zucker Long Island Jewish Hospital
Glen Oaks, New York, 11004
Butler Behavioral Health Services
Hamilton, Ohio, 45011
Jersey Shore Medical Center
Neptune City, New Jersey, 07753
Mount Sinai
New York, New York, 10029
LIJ Zucker Hillside Hospital
New York, New York, 11004
Child Center of New York,
Queens, New York, 11373
NorthShore Child and Family Guidance
Roslyn Heights, New York, 11577
StonyBrook
Stony Brook, New York, 11794
TCN Family Solutions
Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: MOBILITY- Metformin for Overweight & OBese ChILdren and Adolescents With BIpolar Spectrum Disorders Treated With Second-Generation AntipsYchotics

Read the detailed description

The investigators propose to recruit 1800 overweight/obese youth with Bipolar Spectrum Disorder (BSD) who are prescribed second generation anti psychotics (SGAs) from at least 24 public and private mental health practices in the Greater Cincinnati and New York City regions, (approximately 900 each from ~12 Cincinnati region and ~12 Long Island/New York mental health treatment sites) to participate in the proposed patient-centered large pragmatic trial examining the effectiveness of MET and LIFE vs. LIFE alone. Patients will be eligible if they are ages 8-17 years old, inclusive, overweight or obese (BMI > 85%), continuing or starting treatment with at least one SGA (i.e., olanzapine, clozapine, risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone, or asenapine) and have a clinical diagnosis of BSD (bipolar I or II disorder, cyclothymia, or bipolar or mood disorder not otherwise specified [or by Diagnostic and Statistical Manual of Mental Disorders V (DSM-5), other specified bipolar or mood disorder). The enrollment rate will be 2-3 patients/month/site for a recruitment time of 30 months.

Conditions: Bipolar Disorder
Being tested: Metformin, healthy lifestyle intervention (LIFE)
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetforminDrug
Also called GLUCOPHAGE
Metformin - to achieves maximum insulin-sensitizing effects
healthy lifestyle intervention (LIFE)Behavioural
Also called LIFE
Healthy Life style intervention

Study groups in NCT02515773
Study group	Role	What they receive
MET and LIFE	Experimental	Participants randomized to this group will receive both Metformin and lifestyle intervention.Participants randomized to treatment with MET will start at a dose of 500 mg orally at night and slowly titrated in 2-week intervals to ensure that each patient achieves maximum insulin-sensitizing effects of the drug while minimizing the chance of side effects. Investigators will also recommend that MET be taken with food to minimize side effects. If a participant's BMI percentile <5% (=underweight) his/her treatment with MET will be discontinued. Although the risk of low vitamin B12 while taking MET is associated with age > 50 years and having type II diabetes, Investigator will monitor B12 levels and a CBC throughout study participation. Receives: Drug: Metformin; Behavioral: healthy lifestyle intervention (LIFE)
Healthy lifestyle intervention (LIFE)	Experimental	Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP). Receives: Behavioral: healthy lifestyle intervention (LIFE)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in BMI Z-score From Baseline to Month 6 in ITT Sample
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Measured: Baseline to Month 6
Change in BMI Z-score From Baseline to Month 24 in ITT Sample
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Measured: Baseline to Month 24
Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Measured: Baseline to Month 6
Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Measured: Baseline to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015Jun 2023

First posted5 Aug 2015 (estimated)
Study startDec 2015
Primary completionDec 2022
Study completionJun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,565 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02515773
Sponsor's protocol ID: DelBello PCORI
Acronym: MOBILITY
Status last verified: Dec 2024
First submitted: 31 Jul 2015
Last updated: 14 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

DelBello MP, Welge JA, Klein CC, Blom TJ, Fornari V, Higdon C, Sorter MT, Kurtz B, Starr C, Smith A, Huang B, Chen C, Modi AC, Crimmins N, Correll CU; MOBILITY Consortium. Metformin for overweight and obese children and adolescents with bipolar spectrum and related mood disorders treated with second-generation antipsychotics: a randomised, pragmatic trial. Lancet Psychiatry. 2025 Dec;12(12):893-905. doi: 10.1016/S2215-0366(25)00273-1.
PubMed 41233082
Higdon C, Welge JA, Crimmins NA, Klein CC, Fornari VM, Sorter MT, Blom TJ, Kurtz BP, Correll CU, DelBello MP. Metabolic syndrome in youth with bipolar spectrum disorders treated with second-generation antipsychotics: baseline results from the community-based pragmatic MOBILITY Trial. Eur Child Adolesc Psychiatry. 2025 Sep;34(9):2917-2929. doi: 10.1007/s00787-025-02680-2. Epub 2025 Apr 11.
PubMed 40214755
Welge JA, Correll CU, Sorter MT, Fornari VM, Blom TJ, Carle AC, Huang B, Klein CC, DelBello MP. Metformin for Overweight and Obese Children With Bipolar Spectrum Disorders Treated With Second-Generation Antipsychotics (MOBILITY): Protocol and Methodological Considerations for a Large Pragmatic Randomized Clinical Trial. JAACAP Open. 2023 Mar 13;1(1):60-73. doi: 10.1016/j.jaacop.2023.03.004. eCollection 2023 Jun.
PubMed 39554834

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MOBILITY- Metformin for Overweight & OBese ChILdren and Adolescents With BIpolar Spectrum Disorders Treated With Second-Generation AntipsYchotics
ClinicalTrials.gov ID: NCT02515773
Acronym / sponsor ID: MOBILITY / DelBello PCORI
Conditions: Bipolar Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,565 participants (actual)
Lead sponsor: Melissa DelbelloUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: Dec 2015
Primary completion: Dec 2022 (actual)
Study completion: Jun 2023 (actual)
First posted: 5 Aug 2015 (estimated)
Results: Posted 14 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MET and LIFE	Experimental	Drug: Metformin, Behavioral: healthy lifestyle intervention (LIFE)Participants randomized to this group will receive both Metformin and lifestyle intervention.Participants randomized to treatment with MET will start at a dose of 500 mg orally at night and slowly titrated in 2-week intervals to ensure that each patient achieves maximum insulin-sensitizing effects of the drug while minimizing the chance of side effects. Investigators will also recommend that MET be taken with food to minimize side effects. If a participant's BMI percentile <5% (=underweight) his/her treatment with MET will be discontinued. Although the risk of low vitamin B12 while taking MET is associated with age > 50 years and having type II diabetes, Investigator will monitor B12 levels and a CBC throughout study participation.
Healthy lifestyle intervention (LIFE)	Experimental	Behavioral: healthy lifestyle intervention (LIFE)Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP).

Who may qualify

Ages: 8 to 19 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Inpatient or outpatient age 8-19 years inclusive; participants must live with a parent, guardian, or caregiver;
Fluent in English;
Diagnosed or told by a clinician that they have any of the following bipolar spectrum disorders (BSD): bipolar I, bipolar II, unspecified bipolar and related disorders, Disruptive Mood Dysregulation Disorder (DMDD), cyclothymic disorder, other specified bipolar and related disorders, as well as mood disorder not otherwise specified (if diagnosed in the past as per DSM-IV);
Body mass index >85%ile for age and sex by standard growth charts;
Received a new or ongoing prescription for at least one SGA (i.e., olanzapine, clozapine, risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone, brexpiprazole or cariprazine) that is not prescribed as a PRN medication;

Key exclusion criteria (7 listed)

Patients will be excluded if they have had exposure to a total daily dose of MET 1000 mg bid for at least 2 weeks in the past 3 months;
Patients will be excluded if they could not tolerate MET during the recommended titration schedule outlined in the protocol;
Major neurological or medical illnesses that affect weight gain (e.g., unstable thyroid disease) or require a systemic medication that might impact weight or glucose regulation (e.g., diabetes mellitus [insulin], chronic renal failure [steroids]);
Fasting glucose ≥ 126 mg/dL on 2 occasions during screening indicating need for prompt treatment;
If lab results are available in the last 6 months, then a serum creatinine ≥1.3 mg/dL on 2 occasions during screening and/or follow-up, indicating potential impairment of renal functioning;

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
MetforminAlso: GLUCOPHAGEMetformin - to achieves maximum insulin-sensitizing effects	Drug	MET and LIFE
healthy lifestyle intervention (LIFE)Also: LIFEHealthy Life style intervention	Behavioural	Healthy lifestyle intervention (LIFE), MET and LIFE

Primary outcome

Change in BMI Z-score From Baseline to Month 6 in ITT Sample
Time frame: Baseline to Month 6
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Change in BMI Z-score From Baseline to Month 24 in ITT Sample
Time frame: Baseline to Month 24
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample
Time frame: Baseline to Month 6
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample
Time frame: Baseline to Month 24
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.

Results and safety

Results posted to the registry on 14 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MET and LIFE	579	360
Healthy Lifestyle Intervention (LIFE)	720	454

Primary outcome: Change in BMI Z-score From Baseline to Month 6 in ITT Sample

Time frame: Baseline to Month 6. Mean (Standard Deviation). Unit: Z-score

Measure	MET and LIFE n = 565	Healthy Lifestyle Intervention (LIFE) n = 687
Value	-0.08 (0.29)	0.00 (0.29)

MET and LIFE vs Healthy Lifestyle Intervention (LIFE): Mean Difference (Net): 0.08, p <0.001, ANCOVA

Population analysed: Modified intention-to-treat (ITT) sample consisting of patients who initiated randomized treatment and had at least one post-baseline assessment.

Primary outcome: Change in BMI Z-score From Baseline to Month 24 in ITT Sample

Time frame: Baseline to Month 24. Mean (Standard Deviation). Unit: Z-score

Measure	MET and LIFE n = 579	Healthy Lifestyle Intervention (LIFE) n = 720
Value	-0.19 (1.00)	-0.11 (0.87)

MET and LIFE vs Healthy Lifestyle Intervention (LIFE): Mean Difference (Net): 0.07, p = 0.044, ANCOVA

Population analysed: Modified intention-to-treat (ITT) sample consisting of patients who initiated randomized treatment and had at least one post-baseline assessment.

Primary outcome: Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample

Time frame: Baseline to Month 6. Mean (Standard Deviation). Unit: Z-score

Measure	MET and LIFE n = 547	Healthy Lifestyle Intervention (LIFE) n = 656
Value	-0.09 (0.46)	0.00 (0.42)

MET and LIFE vs Healthy Lifestyle Intervention (LIFE): Mean Difference (Net): 0.08, p <0.001, ANCOVA

Population analysed: Per protocol sample consisting of patients who had continuously followed their randomized treatment through month 6

Primary outcome: Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample

Time frame: Baseline to Month 24. Mean (Standard Deviation). Unit: Z-score

Measure	MET and LIFE n = 558	Healthy Lifestyle Intervention (LIFE) n = 686
Value	-0.21 (1.11)	-0.12 (1.01)

MET and LIFE vs Healthy Lifestyle Intervention (LIFE): Mean Difference (Net): 0.09, p = 0.041, ANCOVA

Population analysed: Per protocol sample consisting of patients who had continuously followed their randomized treatment through month 24

Adverse events

Time frame: 30 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MET and LIFE	12 of 579 (2.1%)	352 of 558 (63.1%)	0 of 579
Healthy Lifestyle Intervention (LIFE)	25 of 720 (3.5%)	339 of 686 (49.4%)	0 of 720

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41233082DelBello MP, Welge JA, Klein CC, Blom TJ, Fornari V, Higdon C, Sorter MT, Kurtz B, Starr C, Smith A, Huang B, Chen C, Modi AC, Crimmins N, Correll CU; MOBILITY Consortium. Metformin for overweight and obese children and adolescents with bipolar spectrum and related mood disorders treated with second-generation antipsychotics: a randomised, pragmatic trial. Lancet Psychiatry. 2025 Dec;12(12):893-905. doi: 10.1016/S2215-0366(25)00273-1.
Derived from this study: PubMed 40214755Higdon C, Welge JA, Crimmins NA, Klein CC, Fornari VM, Sorter MT, Blom TJ, Kurtz BP, Correll CU, DelBello MP. Metabolic syndrome in youth with bipolar spectrum disorders treated with second-generation antipsychotics: baseline results from the community-based pragmatic MOBILITY Trial. Eur Child Adolesc Psychiatry. 2025 Sep;34(9):2917-2929. doi: 10.1007/s00787-025-02680-2. Epub 2025 Apr 11.
Derived from this study: PubMed 39554834Welge JA, Correll CU, Sorter MT, Fornari VM, Blom TJ, Carle AC, Huang B, Klein CC, DelBello MP. Metformin for Overweight and Obese Children With Bipolar Spectrum Disorders Treated With Second-Generation Antipsychotics (MOBILITY): Protocol and Methodological Considerations for a Large Pragmatic Randomized Clinical Trial. JAACAP Open. 2023 Mar 13;1(1):60-73. doi: 10.1016/j.jaacop.2023.03.004. eCollection 2023 Jun.
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. This study is not recruiting at the moment.

Melissa P DelBello, MD, MS principal investigator

University of Cincinnati

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin and healthy lifestyle intervention (LIFE) in people with Bipolar Disorder, run by Melissa Delbello at 29 sites 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?

The sponsor lists 5 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in BMI Z-score From Baseline to Month 6 in ITT Sample (time frame: Baseline to Month 6). 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 NCT02515773, which also lists 3 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 14 Jan 2025.