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Growth Hormone DisorderPhase 2NCT02616562

Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

A Phase 2 study testing somapacitan and Norditropin® FlexPro® pen in people with Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 89 sites in 14 countries.

Completed

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

Official record
Search all trials

Trial summary

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency. Read more about this study

Who is it for?
Ages 2 to 10 years
What is being tested?
somapacitan and Norditropin® FlexPro® pen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
89 sitesin 14 countries
Study dates
31 Mar 2016to 26 Sep 2024
Phase
Phase 2
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 2 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Boys: Tanner stage 1 for pubic hair and testis volume below 4 ml , age at least 2 years and 26 weeks and below or equal to 10.0 years at screening
  • Girls: Tanner stage 1 for breast development (no palpable glandular breast tissue) and pubic hair, age at least 2 years and 26 weeks and below or equal to 9.0 years at screening
  • Confirmed diagnosis of GHD (growth hormone deficiency) within 12 months prior to screening as determined by two different GH (growth hormone) stimulation tests, defined as a peak GH level of below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test is needed
  • No prior exposure to GH therapy and/or IGF-I (insulin-like growth factor I) treatment
  • Height of at least 2.0 standard deviations below the mean height for chronological age (CA) and gender according to the standards of Centers for Disease Control and Prevention 2-20 years: Girls/Boys stature-for-age and weight-for-age percentiles CDC at screening
  • Annualized height velocity (HV) below the 25th percentile for CA (chronological age) and gender or below -0.7 SD (standard deviation) score for CA and sex, according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months

Who cannot join

  • Any clinically significant abnormality likely to affect growth or the ability to evaluate
  • growth with standing measurements: Chromosomal aneuploidy and significant gene mutations causing medical "syndromes" with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors. Congenital abnormalities (causing skeletal abnormalities), including but not limited to Russell-Silver Syndrome, skeletal dysplasias. Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants
  • Children born small for gestational age (SGA - birth weight and/or birth length below-2 SD for gestational age)
  • Concomitant administration of other treatments that may have an effect on growth, including but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD)
  • Prior history or presence of malignancy and/or intracranial tumour

Trial locations and contacts

89 sites in 14 countries.

89 sites in 14 countries

United States27 sites

  • Dell Pediatric Research Institute

    Austin, Texas, 78723

  • Children's of Alabama

    Birmingham, Alabama, 35233

  • UBMD Peds-Div of Endo/Diabetes

    Buffalo, New York, 14203

  • Rocky Mt Ped and Endo

    Centennial, Colorado, 80112

  • Childrens Hospital of Chicago

    Chicago, Illinois, 60611

  • CCHMC_Cinc

    Cincinnati, Ohio, 45229

  • Novo Nordisk Clinical Trial Call Center

    Cincinnati, Ohio, 45229

  • Ped Endo Assoc PC-G.V

    Greenwood Village, Colorado, 80111-2803

  • Riley Hospital For Children

    Indianapolis, Indiana, 46202

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California, 90027

  • Mattel Children's Hospital at UCLA

    Los Angeles, California, 90095

  • Valley Children's Hospital

    Madera, California, 93636-8762

  • Novo Nordisk Clinical Trial Call Center

    Mineola, New York, 11501

  • NYU Langone Hospital-LI

    Mineola, New York, 11501

  • Novo Nordisk Clinical Trial Call Center

    Minneapolis, Minnesota, 55454

  • University of Minnesota_Minneapolis_2

    Minneapolis, Minnesota, 55454

  • Goryeb Children's Hospital

    Morristown, New Jersey, 07962

  • Novo Nordisk Clinical Trial Call Center

    Morristown, New Jersey, 07962

  • Rutgers-Rwjms

    New Brunswick, New Jersey, 08901

  • Children's Hsptl Of The Kings

    Norfolk, Virginia, 23507

  • The Endocrine Center

    Pembroke Pines, Florida, 33028

  • Endocrine Associates Of Dallas

    Plano, Texas, 75093

  • Novo Nordisk Clinical Trial Call Center

    San Diego, California, 92123

  • The Regents of the Univ of CA

    San Diego, California, 92123

  • MultiCare Inst for Res & Innov

    Tacoma, Washington, 98405

  • University Of Oklahoma-Tulsa

    Tulsa, Oklahoma, 74135

  • Nemours/AI duPont Hosp-Chld

    Wilmington, Delaware, 19803

Other trials in United States

Japan11 sites

  • Kyushu Univ. HP, Maternity & Perinatal Care Center

    Fukuoka, 812-8582

  • Kurume University Hospital, Pediatrics

    Fukuoka, 830-0011

  • St. Marianna University School of Medicine Hospital_Pediatrics

    Kanagawa, 216-8511

  • Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics

    Kyoto, 602-8566

  • Osaka City General Hospital, Pediatric Endocrinology and Me

    Osaka, 534-0021

  • JCHO Osaka Hospital_Pediatric

    Osaka, 553-0003

  • Osaka Women's and Children's Hospital

    Osaka, 594-1101

  • Institute of Science Tokyo Hospital_Pediatrics

    Tokyo, 113-8519

  • Tokyo Medical and Dental University Hospital

    Tokyo, 113-8519

  • National Center for Child Health and Dev, Endo and Metabo

    Tokyo, 157 8535

  • Study site

    Tokyo, 157 8535

Other trials in Japan

Austria7 sites

  • Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie

    Graz, 8036

  • Study site

    Graz, 8036

  • Kepler Universitätsklinikum GmbH - Med Campus IV (vorm.LFKK)

    Linz, Upper Austria, 4020

  • LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde

    Salzburg, 5020

  • LKH St. Poelten, Kinder-und Jugendheilkunde

    Sankt Pölten, 3100

  • Landeskrankenhaus Villach

    Villach, 9500

  • Salzkammergut-Klinikum Vöcklabruck

    Vöcklabruck, 4840

Other trials in Austria

France7 sites

  • Centre Hospitalier Universitaire D'Angers-2

    Angers, 49033

  • Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin

    Bordeaux, 33076

  • Study site

    Bordeaux, 33076

  • Centre Hospitalier Universitaire de Nantes-Hopital Enfant-Adolescent

    Nantes, 44000

  • Ap-Hp-Hopital Necker

    Paris, 75015

  • HOPITAL SUD de RENNES

    Rennes, 35056

  • HOPITAL DES ENFANTS-HOPITAL PAULE DE VIGUIER - Pharmacie

    Toulouse, 31059

Other trials in France

Israel6 sites

  • Soroka MC - Pediatric Endocrinology

    Beersheba, 84101

  • Rambam MC - Department of Pediatrics A

    Haifa, 31096

  • Meir MC - Department of Paediatrics

    Kfar Saba, 44281

  • Study site

    Kfar Saba, 44281

  • Schneider MC - Endrocrinology and Diabetes

    Petah Tikva, 49202

  • Sheba MC - Pediatric endocrinology and adolescent diabetes clinics

    Tel HaShomer, 52621

Other trials in Israel

Turkey (Türkiye)6 sites

  • Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi

    Adana, 01130

  • Hacettepe Üniversitesi Hastanesi- Endokrinoloji

    Ankara, 06230

  • I.U Istanbul Medical Faculty

    Istanbul, 34093

  • Study site

    Istanbul, 34093

  • Marmara University Medical Faculty

    Istanbul, 34854

  • Marmara Üniversitesi Pendik EAH- Başıbüyük Yerleşkesi- Kardiyoloji

    Istanbul, 34854

Other trials in Turkey (Türkiye)

Belgium5 sites

  • UZ Brussel

    Brussels, 1090

  • Study site

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc - Serv. Pédiatrie

    Brussels, 1200

  • UZ Leuven - Kindergeneeskunde

    Leuven, 3000

  • CHU de Liège, site N.-D. des Bruyères

    Liège, 4030

Other trials in Belgium

Brazil4 sites

  • Serviço de Endocrinologia e Metabologia do HC-UFPR

    Curitiba, Paraná, 80030-110

  • Hospital São Lucas - PUC/RS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, São Paulo, 01228-000

  • Study site

    São Paulo, São Paulo, 01228-000

Other trials in Brazil

India4 sites

  • Amrita Institute Of Medical Sciences & Research Centre

    Kochi, Kerala, 682041

  • All India Institute of Medical Sciences

    New Dehli, New Delhi, 110029

  • Study site

    New Dehli, New Delhi, 110029

  • Jehangir Clinical Development Centre

    Pune, Maharashtra, 411001

Other trials in India

Germany3 sites

  • Study site

    Frankfurt, 60596

  • Endokrinologikum Frankfurt

    Frankfurt am Main, 60596

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

    Ulm, 89075

Other trials in Germany

Sweden3 sites

  • Astrid Lindgrens Barnsjukhus

    Stockholm, 171 76

  • Study site

    Stockholm, 171 76

  • Barn och ungdomscentrum Västerbotten

    Umeå, 901 85

Other trials in Sweden

Ukraine3 sites

  • Ivano-Frankivsk Regional Clinical Children Hospital - Endocrinology dept.

    Ivano-Frankivsk, 76018

  • Study site

    Kiev, 04114

  • Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology

    Kyiv, 04114

Other trials in Ukraine

Slovenia2 sites

  • University Children's Hospital

    Ljubljana, 1525

  • Study site

    Ljubljana, 1525

Other trials in Slovenia

Canada1 site

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: A Randomised, Multinational, Active-controlled, (Open-labelled), Dose Finding, (Double-blinded), Parallel Group Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency.

The main trial period will consist of 26 weeks of treatment, followed by a 26 week extension period.

Being tested
somapacitan, Norditropin® FlexPro® pen

What participants receive

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

  • somapacitanDrug

    Also called NNC0195-0092

    Administered subcutaneously (s.c., under the skin) once-weekly.

  • Norditropin® FlexPro® penDrug

    Administered subcutaneously (s.c., under the skin) once daily.

Study groups in NCT02616562
Study groupRoleWhat they receive
Cohort I Norditropin/somapacitanExperimentalParticipants received Norditropin subcutaneously daily in main trial period, extension trial period and safety extension trial period. After completing the safety extension trial period (week 156), participants who received Norditropin were allocated to open-labelled Somapacitan dose 3 subcutaneously once weekly for the 208-week (up till week 364) long-term safety extension period. After week 364, participants received somapacitan dose 3 subcutaneously once weekly until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
Receives: Drug: somapacitan; Drug: Norditropin® FlexPro® pen
Cohort I somapacitan pooledExperimentalParticipants were randomized (1:1:1) to receive Somapacitan treatment (dose 1/dose 2/dose 3) subcutaneously once-weekly during the 26-week main trial period and the 26-week extension trial period. After completing the main and extension trial periods (week 52), all participants initially randomized to double-blinded Somapacitan received open-labelled Somapacitan dose 3 for the 104-week safety extension trial period. After completing the safety extension trial period (week 156), all participants in cohort I were allocated to open-labelled somapacitan dose 3 for the 208-week (up till week 364) long-term safety extension period. In extension after week 364 period participants received somapacitan dose 3 subcutaneously once weekly until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
Receives: Drug: somapacitan
Cohort II somapacitan previously treatedExperimentalParticipant who was previously treated with GH (Growth hormone) prior to enrollment in the trial at week 156, received somapacitan dose 3 subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
Receives: Drug: somapacitan
Cohort III somapacitan treatment naiveExperimentalParticipants who were naive to treatment with GH prior to enrolment in the trial at week 156, received open-labelled somapacitan dose 3 subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
Receives: Drug: somapacitan
Cohort III somapacitan previously treatedExperimentalParticipants who were previously treated with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan dose 3 subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
Receives: Drug: somapacitan

What is being measured

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

  1. Height Velocity (HV) (cm/Year) During the First 26 Weeks of Treatment, Measured as Standing Height With Stadiometer

    Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 26 as: HV = (height at 26 weeks visit- height at baseline) / (time from baseline to 26 weeks visit in years).

    Measured: Baseline (week 0), week 26

  2. Cohort II and Cohort III - Adverse Events Rate, Including Injection Site Reactions in Children With GHD.

    This primary outcome measure was analysed by cohort using descriptive statistics. Adverse event per 100 patient years are presented in this outcome measure.

    Measured: From week 156 up to week 364

Secondary outcomes (12)

  1. Cohort I: Change in Height Standard Deviation Score (HSDS)

    Change in height standard deviation score is presented from baseline (week 0) to end of the main trial period week 26 and end of extension trial period week 52. The formula to calculate HSDS is: HSDS = ((Height / M)**L-1) / (L*S). L: The gender and age-specific power in the Box-Cox transformation, M: The gender and age-specific median, S: The gender and age-specific generalized coefficient of variation. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender.

    Measured: Baseline (Week 0), week 26, week 52

  2. Cohort I: Change in Height Velocity Standard Deviation Score (HVSDS)

    Change in height velocity standard deviation score is presented from baseline (week 0) to end of main trial period week 26 and end of extension trial period week 52. HVSDS was calculated using the formula: HVSDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HVSDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender.

    Measured: Baseline (Week 0), week 26, week 52

  3. Cohort I: Adverse Events Rate, Including Injection Site Reactions

    Adverse events per 100 patient years are presented. AEs with an onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up until visit 32 (week 364) or 14 days after last trial drug administration, which ever comes first, for all other participants, are analysed.

    Measured: From week 0 Up to week 364

  4. Cohort I: Occurrence of Anti-NNC0195-0092 and Anti-hGH Antibodies

    Participants who developed anti-NNC0195-0092 and anti-hGH antibodies are reported in this outcome measure.

    Measured: From week 0 Up to week 364

  5. Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS)

    Change in IGF-I SDS is presented from baseline (week 0) to end of main trial period week 26 and end of extension period week 52. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender.

    Measured: (Week 0), week 26, week 52

  6. Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS)

    Change in IGFBP-3 SDS is presented from baseline (week 0) to end of main trial period week 26 and end of extension trial period week 52. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender.

    Measured: Baseline (Week 0), week 26, week 52

  7. Height Velocity (HV) (cm/Year) at Weeks 52 (Derived From Standing Height)

    HV was derived from height measurements taken at baseline (week 0) and the week 52 as: HV = (height at 52 weeks visit-height at baseline) / (time from baseline to 52 weeks visit in years)

    Measured: Baseline (week 0); week 52

  8. Bone Age Progression vs. Chronological Age Ratio

    The bone age vs. chronological age ratio is presented at week 52. X-Ray of left hand and wrist, central assessed according to Greulich \& Pyle atlas were taken.

    Measured: At week 52

  9. Serum Somapacitan Concentrations

    Serum somapacitan concentrations are presented at week 52.

    Measured: At week 52

  10. Changes in Emotional Well-being Score, Physical Health Score, Social Well-being Score and Total Score in TRIM-CGHD-O (Treatment Related Impact Measure - Child Growth Hormone Deficiency- Observer)

    Change in Treatment Related Impact Measure from baseline (week 0) to week 26 and week 52 were assessed in children with growth hormone deficiency. This outcome measure was assessed using patient reported outcome (PRO) questionnaires with 3 domains, such as emotional well-being score, physical health score, social wellbeing core and total score. The total score was calculated by taking average of each domain. The scale range for each domain and total score was from 0-100 and a lower score indicates a better health state. TRIMCGHD-O was analysed using descriptive statistics.

    Measured: Baseline (Week 0), week 26, week 52

  11. Total Score of TB-CGHD-O (The Treatment Burden Measure - Child Growth Hormone Deficiency - Observer)

    Total score of Treatment Burden Measure (observer) was assessed at week 26 and at week 52 in children with growth hormone deficiency. This outcome measure was assessed using PRO questionnaires. The scale range for total score was from 0-100 and a lower score indicates a better health state.

    Measured: At week 26, at week 52

  12. Total Score of TB-CGHD-P (The Treatment Burden Measure - Child Growth Hormone Deficiency - Parent/Guardian)

    Total score of Treatment Burden Measure (parent/guardian) is reported at week 26 and at week 52 in children with growth hormone deficiency. This outcome measure was assessed using PRO questionnaires. The scale range for total score was from 0-100 and a lower score indicates a better health state.

    Measured: At week 26, at week 52

Timeline

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

  1. First posted30 Nov 2015 (estimated)
  2. Study start31 Mar 2016
  3. Primary completion26 Sep 2024
  4. Study completion26 Sep 2024

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02616562
Sponsor's protocol ID
NN8640-4172
Other IDs
2015-000531-32, U1111-1166-7062, 2015
Status last verified
Dec 2025
First submitted
25 Nov 2015
Last updated
16 Jan 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Savendahl L, Battelino T, Hojby Rasmussen M, Brod M, Rohrich S, Saenger P, Horikawa R. Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety, and Treatment/Disease Burden Results From REAL 3. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2569-2578. doi: 10.1210/clinem/dgad183.

    PubMed 36995872

  • Savendahl L, Battelino T, Hojby Rasmussen M, Brod M, Saenger P, Horikawa R. Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1357-1367. doi: 10.1210/clinem/dgab928.

    PubMed 34964458

  • Savendahl L, Battelino T, Brod M, Hojby Rasmussen M, Horikawa R, Juul RV, Saenger P; REAL 3 study group. Once-Weekly Somapacitan vs Daily GH in Children With GH Deficiency: Results From a Randomized Phase 2 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1847-61. doi: 10.1210/clinem/dgz310.

    PubMed 31917835

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing somapacitan and Norditropin® FlexPro® pen in people with Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 89 sites in 14 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: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Japan, Austria, France, Israel and 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 Jan 2026). 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?

Height Velocity (HV) (cm/Year) During the First 26 Weeks of Treatment, Measured as Standing Height With Stadiometer (time frame: Baseline (week 0), week 26). The study lists 2 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 NCT02616562, 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 16 Jan 2026.

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