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ObesityPhase 3STEP YoungNCT05726227

A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight

A Phase 3 study testing Semaglutide in people with Obesity, run by Novo Nordisk A/S at 56 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Obesity
What is being tested?
Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
212 participants
Where
56 sitesin 10 countries
Study dates
7 Jul 2023to 7 Dec 2026
Phase
Phase 3
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 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. a) The parents or LAR of the child must sign and date the Informed Consent Form (according to local requirements) b) The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)
  • Age at the time of signing informed consent. a)Group Kids: 6 to less than 12 years. b) Group Teens: 12 to less than 18 years and Tanner stage greater than 1
  • Body mass index (BMI), at screening and randomisation, corresponding to a) Group Kids: greater than or equal to 95th percentile. b) Group Teens: greater than or equal to 95th percentile or greater than or equal to 85th percentile with the presence of at least 1 weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes mellitus (T2D)
  • History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months
  • Body weight of greater than 45 kilogram (kg) at screening and randomisation
  • For participants with T2D at screening, the following additional criterion applies: glycated haemoglobin (HbA1c) less than or equal to 10.0 percent (86 millimoles per mole [mmol/mol]) as measured by central laboratory at screening

Who cannot join

  • Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
  • Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: a) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening. b) adjustable gastric banding, if the band has been removed greater than 1 year prior to screening. c) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening. d)duodenal-jejunal bypass liner (e.g., nonbarrier), if the sleeve has been removed greater than 1 year prior to screening
  • Type 1 diabetes mellitus or monogenic diabetes
  • Participants with endocrine, hypothalamic, or syndromic obesity
  • For participants with T2D at screening, the following additional key criterion applies: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Trial locations and contacts

56 sites in 10 countries.

56 sites in 10 countries

United States24 sites

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78731

  • Barry J. Reiner, MD LLC

    Baltimore, Maryland, 21229

  • Pennington Biom Res Ctr

    Baton Rouge, Louisiana, 70808

  • Massachusetts General Hospital_Cary

    Boston, Massachusetts, 02114

  • UBMD Peds-Div of Endo/Diabetes

    Buffalo, New York, 14203

  • Columbus Research Foundation

    Columbus, Georgia, 31904

  • Centricity Research - Ohio

    Columbus, Ohio, 43213

  • Neighborhood Healthcare

    Escondido, California, 92025

  • Valley Weight Loss Clinic

    Fargo, North Dakota, 58104

  • Mississippi Center for Advanced Medicine

    Madison, Mississippi, 39110

  • Mississippi CTR for ADV MED

    Madison, Mississippi, 39110

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • University of Minnesota

    Minneapolis, Minnesota, 55414

  • Clinical Trials of America LLC

    Monroe, Louisiana, 71201

  • IMA Clinical Research

    Monroe, Louisiana, 71201

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Yale School of Medicine

    New Haven, Connecticut, 06519

  • Health Res of Hampton Roads

    Newport News, Virginia, 23606

  • UPMC Child Hosp-Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • WakeMed Childn Endo-Dbt_Raleig

    Raleigh, North Carolina, 27610

  • Univ Of Texas Hlth Science Cntr

    San Antonio, Texas, 78207

  • Eastside Bariatric and Gen Surg

    Snellville, Georgia, 30078

  • Pediatric Clinical Trials, LLC

    Tullahoma, Tennessee, 37388

Other trials in United States

Germany7 sites

  • Universitätsklinikum Halle - Innere Medizin II

    Halle, 06120

  • Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung

    Hanover, 30173

  • Kinder- und Jugendkrankenhaus

    Hanover, 30173

  • Uniklinik Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin

    Leipzig, 04103

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin

    Leipzig, 04103

  • Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)

    Ulm, 89075

  • Universitätsklinikum Ulm für Kinder- und Jugendmedizin

    Ulm, 89075

Other trials in Germany

United Kingdom5 sites

  • Birmingham Children's Hospital

    Birmingham, B4 6NH

  • University Hospitals Bristol & Weston NHS Foundation Trust

    Bristol, BS2 8BJ

  • Leeds Children's Hospital

    Leeds, LS1 3EX

  • Alder Hey Children's Hospital

    Liverpool, L12 2AP

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Belgium4 sites

  • UZ Brussel

    Brussels, 1090

  • UZ Antwerpen - UZA - Kinderziekenhuis

    Edegem, 2650

  • UZA - UZ Antwerpen - Kinderziekenhuis

    Edegem, 2650

  • UZ Leuven - Kindergeneeskunde

    Leuven, 3000

Other trials in Belgium

Sweden4 sites

  • Drottning Silvias barnsjukhus

    Gothenburg, 41650

  • Hallands sjukhus Halmstad

    Halmstad, 30233

  • Akademiska sjukhuset Uppsala

    Uppsala, 75185

  • Uppsala universitetssjukhus

    Uppsala, 75185

Other trials in Sweden

Denmark3 sites

  • Aarhus Universitetshospital, Steno Diabetes Center Aarhus

    Aarhus, 8200

  • Aalborg Universitetshospital - Børne og Ungeafdelingen

    Gistrup, 9260

  • Holbæk Sygehus - Børne- og Ungeafdelingen

    Holbæk, 4300

Other trials in Denmark

Israel3 sites

  • Rambam MC - Department of Pediatrics A

    Haifa, 31096

  • Schneider MC - Endrocrinology and Diabetes

    Petah Tikva, 49202

  • Shamir MC - Pediatric and Adolescents Endocrinology unit

    Tsrifin, 7033001

Other trials in Israel

Portugal3 sites

  • Hospital da Luz Lisboa, S.A.

    Lisbon, 1500-650

  • ULS De Santo António, E.P.E. - Hospital de Santo António

    Porto, 4050-342

  • Hospital CUF Porto S.A.

    Porto, 4100-180

Other trials in Portugal

Austria2 sites

  • Universitätsklinik Kinder-Jugendheilkunde Innsbruck

    Innsbruck, 6020

  • Universitätsklinik für Kinder und Jugendheilkunde Haus E

    Salzburg, 5020

Other trials in Austria

Mexico1 site

  • Consultorio de Endocrinología y Pediatría

    Puebla City, 72190

Other trials in Mexico

About this study

Official title: Long-term Safety and Efficacy of Semaglutide s.c. Once-weekly on Weight Management in Children and Adolescents (Aged 6 to <18 Years) With Obesity or Overweight

This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight. The child will either get semaglutide or a "dummy" medicine. Which treatment the child will get is decided by chance. Semaglutide is an approved medicine for type 2 diabetes and weight management in adults.

The child will get one injection once a week. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. The study will last for about 2 ½ years (132 weeks).

Conditions
Obesity
Being tested
Semaglutide, Placebo
Medical subject headings
Obesity

What participants receive

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

  • SemaglutideDrug

    Semaglutide will be administered subcutaneously once weekly.

  • PlaceboDrug

    Placebo will be administered subcutaneously once-weekly.

Study groups in NCT05726227
Study groupRoleWhat they receive
Group KidsExperimentalParticipants in the age group 6 to less than (<) 12 years will receive once weekly subcutaneous (s.c.) injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.
Receives: Drug: Semaglutide; Drug: Placebo
Group TeensExperimentalParticipants in the age group 12 to < 18 years will receive once weekly s.c. injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.
Receives: Drug: Semaglutide; Drug: Placebo

What is being measured

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

  1. Group Kids: Change in body mass index (BMI)

    Measured in percentage (%)

    Measured: From baseline (week 0) to week 68

Secondary outcomes (69)

  1. Group Kids: Improvement in weight category

    Measured as count of participants. Weight categories based on growth charts from Center for Disease Control (CDC).gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.

    Measured: From baseline (week 0) to week 68

  2. Group Teens: Change in BMI

    Measured in %

    Measured: From week 0 to week 68

  3. Group Kids and Group Teens: Change in BMI

    Measured in %

    Measured: From week 0 to week 104

  4. Group Teens: Improvement in weight category

    Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.

    Measured: From week 0 to week 68

  5. Group Kids and Group Teens: Improvement in weight category

    Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.

    Measured: From week 0 to week 104

  6. Group Kids and Group Teens: Change in body weight

    Measured in percentage

    Measured: From week 0 to week 68

  7. Group Kids and Group Teens: Change in body weight

    Measured in percentage

    Measured: From week 0 to week 104

  8. Group Kids and Group Teens: Change in body weight

    Measured in kilograms (kg)

    Measured: From week 0 to week 68

  9. Group Kids and Group Teens: Change in body weight

    Measured in kilograms (kg)

    Measured: From week 0 to week 104

  10. Group Kids and Group Teens: Change in BMI percentage of the 95th percentile

    Measured in percentage points

    Measured: From week 0 to week 68

  11. Group Kids and Group Teens: Change in BMI percentage of the 95th percentile

    Measured in percentage points

    Measured: From week 0 to week 104

  12. Group Kids and Group Teens: Change in BMI Standard deviation score (SDS)

    Measured as score on a scale. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.

    Measured: From week 0 to week 68

  13. Group Kids and Group Teens: Change in BMI SDS

    Measured as score in a scale. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.

    Measured: From week 0 to week 104

  14. Group Kids and Group Teens: Change in waist circumference

    Measured in centimeters (cm)

    Measured: From week 0 to week 68

  15. Group Kids and Group Teens: Change in waist circumference

    Measured in centimeters (cm)

    Measured: From week 0 to week 104

  16. Group Kids and Group Teens: Change in systolic blood pressure

    Measured in millimeters of mercury (mmHg)

    Measured: From week 0 to week 68

  17. Group Kids and Group Teens: Change in systolic blood pressure

    Measured in millimeters of mercury (mmHg)

    Measured: From week 0 to week 104

  18. Group Kids and Group Teens: Change in diastolic blood pressure

    Measured in mmHg

    Measured: From week 0 to week 68

  19. Group Kids and Group Teens: Change in diastolic blood pressure

    Measured in mmHg

    Measured: From week 0 to week 104

  20. Group Kids and Group Teens: Change in total cholesterol

    Measured in %

    Measured: From week 0 to week 68

  21. Group Kids and Group Teens: Change in total cholesterol

    Measured in %

    Measured: From week 0 to week 104

  22. Group Kids and Group Teens: Change in high density lipoprotein (HDL)

    Measured in %

    Measured: From week 0 to week 68

  23. Group Kids and Group Teens: Change in high density lipoprotein (HDL)

    Measured in %

    Measured: From week 0 to week 104

  24. Group Kids and Group Teens: Change in low density lipoprotein (LDL)

    Measured in %

    Measured: From week 0 to week 68

  25. Group Kids and Group Teens: Change in low density lipoprotein (LDL)

    Measured in %

    Measured: From week 0 to week 104

  26. Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)

    Measured in %

    Measured: From week 0 to week 68

  27. Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)

    Measured in %

    Measured: From week 0 to week 104

  28. Group Kids and Group Teens: Change in triglycerides

    Measured in %

    Measured: From week 0 to week 68

  29. Group Kids and Group Teens: Change in triglycerides

    Measured in %

    Measured: From week 0 to week 104

  30. Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)

    Measured in %

    Measured: From week 0 to week 68

  31. Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)

    Measured in %

    Measured: From week 0 to week 104

  32. Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)

    Measured in % point

    Measured: From week 0 to week 68

  33. Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)

    Measured in % point

    Measured: From week 0 to week 104

  34. Group Kids and Group Teens: Change in fasting plasma glucose

    Measured in millimoles per liter (mmol/L)

    Measured: From week 0 to week 68

  35. Group Kids and Group Teens: Change in fasting plasma glucose

    Measured in millimoles per liter (mmol/L)

    Measured: From week 0 to week 104

  36. Group Kids and Group Teens: Change in fasting plasma glucose

    Measured in milligrams per deciliter (mg/dL)

    Measured: From week 0 to week 68

  37. Group Kids and Group Teens: Change in fasting plasma glucose

    Measured in milligrams per deciliter (mg/dL)

    Measured: From week 0 to week 104

  38. Group Kids and Group Teens: Change in fasting insulin

    Measured in %

    Measured: From week 0 to week 68

  39. Group Kids and Group Teens: Change in fasting insulin

    Measured in %

    Measured: From week 0 to week 104

  40. Group Kids and Group Teens: Change in alanine transaminase (ALT)

    Measured in milliunits per liter (mU/L)

    Measured: From week 0 to week 68

  41. Group Kids and Group Teens: Change in alanine transaminase (ALT)

    Measured in milliunits per liter (mU/L)

    Measured: From week 0 to week 104

  42. Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass

    Measured in % points

    Measured: From week 0 to week 68

  43. Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass

    Measured in % points

    Measured: From week 0 to week 104

  44. Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass

    Measured in % points

    Measured: From week 0 to week 68

  45. Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass

    Measured in % points

    Measured: From week 0 to week 104

  46. Group Kids and Group Teens: Relative change in visceral fat mass by DXA

    Measured in %

    Measured: From week 0 to week 68

  47. Group Kids and Group Teens: Relative change in visceral fat mass by DXA

    Measured in %

    Measured: From week 0 to week 104

  48. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)

    Measured in count of participants

    Measured: From week 0 to week 68

  49. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)

    Measured in count of participants

    Measured: From week 0 to week 104

  50. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)

    Measured in count of participants

    Measured: From week 0 to week 68

  51. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)

    Measured in count of participants

    Measured: From week 0 to week 104

  52. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)

    Measured in count of participants

    Measured: From week 0 to week 68

  53. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)

    Measured in count of participants

    Measured: From week 0 to week 104

  54. Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)

    Measured as count of events

    Measured: From week 0 to week 68

  55. Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)

    Measured as count of events

    Measured: From week 0 to week 111

  56. Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)

    Measured as count of events

    Measured: From week 0 to week 68

  57. Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)

    Measured as count of events

    Measured: From week 0 to week 111

  58. Group Kids and Group Teens: Change in pulse

    Measured as beats per minute

    Measured: From week 0 to week 68

  59. Group Kids and Group Teens: Change in pulse

    Measured as beats per minute

    Measured: From week 0 to week 104

  60. Group Kids and Group Teens: Change in amylase

    Measured as units per liter (U/L)

    Measured: From week 0 to week 68

  61. Group Kids and Group Teens: Change in amylase

    Measured as units per liter (U/L)

    Measured: From week 0 to week 104

  62. Group Kids and Group Teens: Change in lipase

    Measured as U/L

    Measured: From week 0 to week 68

  63. Group Kids and Group Teens: Change in lipase

    Measured as U/L

    Measured: From week 0 to week 104

  64. Group Kids and Group Teens: Change in calcitonin

    Measured as nanograms per liter (ng/L)

    Measured: From week 0 to week 68

  65. Group Kids and Group Teens: Change in calcitonin

    Measured as nanograms per liter (ng/L)

    Measured: From week 0 to week 104

  66. Group Kids and Group Teens: Change in bone mineral density, by DXA

    Measured as grams per square centimeter (g/cm^2)

    Measured: From week 0 to week 68

  67. Group Kids and Group Teens: Change in bone mineral density, by DXA

    Measured as grams per square centimeter (g/cm^2)

    Measured: From week 0 to week 104

  68. Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)

    Measured as count of episodes

    Measured: From week 0 to week 68

  69. Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)

    Measured as count of episodes

    Measured: From week 0 to week 111

Timeline

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

  1. First posted13 Feb 2023
  2. Study start7 Jul 2023
  3. Primary completion15 Oct 2025
  4. Study completion7 Dec 2026 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726227
Sponsor's protocol ID
NN9536-4512
Other IDs
U1111-1266-3808, 2022-502922-41
Acronym
STEP Young
Status last verified
Oct 2026
First submitted
3 Feb 2023
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide in people with Obesity, run by Novo Nordisk A/S at 56 sites in 10 countries.

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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Germany, United Kingdom, Belgium, Sweden and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

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?

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?

Group Kids: Change in body mass index (BMI) (time frame: From baseline (week 0) to week 68). 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 NCT05726227.

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 7 Oct 2026.

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