Sickle Cell DiseasePhase 3Hibiscus 2NCT06612268
A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease
A Phase 3 study testing Etavopivat in people with Sickle Cell Disease, run by Novo Nordisk A/S at 175 sites in 21 countries.
Trial summary
This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Etavopivat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 175 sitesin 21 countries
- Study dates
- 17 Feb 2025to 12 Aug 2029
- Phase
- Phase 3
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female.
- Age 12 years or above at the time of signing the informed consent.
- Confirmed diagnosis of sickle cell disease: Documentation of sickle cell disease (SCD) genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing or screening test results from central laboratory. Molecular genotyping is not required. SCD genotype may be determined from the results of haemoglobin (Hb) electrophoresis, high-performance liquid chromatography (HPLC) or similar testing. Note that Hb electrophoresis is performed by the central laboratory at screening.
- Have 2-15 episodes of documented vaso occlusive crises (VOC) within the 12 months prior to screening. Documentation must exist in the participant's medical record prior to randomisation. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.
- Hb greater than or equal to (≥) 5.0 and less than or equal to (≤) 10.0 g/dL (greater than or equal to (≥) 50 and less than or equal to (≤) 100 grams per litre [g/L]) at screening.
Who cannot join
- Use of voxelotor or similar agent within 28 days prior to starting study treatment or anticipated need for this agent during the study.
- Use of a selectin antagonist (e.g., crizanlizumab, monoclonal antibody or small molecule) within 28 days or 5 half-lives (whichever is longer) prior to starting study treatment or anticipated need for such agents during the study.
- Receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or greater than or equal to 6 transfusion events within the previous 12 months prior to screening (i.e., an average of 1 transfusion event every 60 days).
- Participants who have received an RBC transfusion for any reason within 60 days of the screening period or 60 days of the randomisation day are only eligible if HbA (adult haemoglobin) less than 10% by Hb electrophoresis is documented prior to starting study treatment.
- Receiving or use of concomitant medications that are strong or moderate inducers of CYP3A4 (cytochrome p450 3a4) within 2 weeks of starting study treatment or anticipated need for such agents during the study.
- Use of erythropoietin or other haematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study.
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- Receipt of prior cellular-based therapy (e.g., haematopoietic cell transplant, gene modification therapy).
- Hepatic dysfunction characterized by:
- Alanine aminotransferase (ALT) greater than 4.0 × upper limit of normal (ULN) or
- Direct bilirubin greater than 3.0 × ULN.
- Participants who are not taking or are unable to take antimalarial prophylaxis at the time of consent and during the study if they live in areas of endemic malaria where prophylaxis is recommended.
- Severe renal dysfunction (estimated glomerular filtration rate [eGFR] at screening, calculated by the central laboratory greater than 30 mL/min/1.73 m^ 2) or on chronic dialysis.
- Travelled distance on standardized 6MWT below 100m at screening.
Trial locations and contacts
175 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
175 sites in 21 countries
United States50 sites, 44 recruiting
- Recruiting
Children's Healthcare Atlanta
Atlanta, Georgia, 30329
- Completed
Clinical and Transl Res Center
Aurora, Colorado, 80045
- Recruiting
Uni of Alabama at Birmingham
Birmingham, Alabama, 35233
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118-2393
- Recruiting
NYC Health+Hospitals
Brooklyn, New York, 11203
- Recruiting
Interfaith Medical Center
Brooklyn, New York, 11238
- Recruiting
Childrens Hospital of Chicago
Chicago, Illinois, 60611
- Recruiting
Univer Of Illinois at Chicago
Chicago, Illinois, 60612
- Recruiting
Univ Hosp Cleveland Med Ctr
Cleveland, Ohio, 44106
- Recruiting
Ohio State Univ Wexner Med Ctr
Columbus, Ohio, 43203
- Completed
Henry Ford Hospital_Detroit
Detroit, Michigan, 48202
- Recruiting
Duke Comprehen Sickle Cell
Durham, North Carolina, 27710
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Recruiting
Inova Health System
Fairfax, Virginia, 22031
- Recruiting
East Carolina Univ-Greenville
Greenville, North Carolina, 27834
- Recruiting
Memorial Healthcare
Hollywood, Florida, 33021
- Recruiting
UT Health University of Texas
Houston, Texas, 77030
- Completed
Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
- Recruiting
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, 90027
- Completed
UCLA Health
Los Angeles, California, 90095
- Recruiting
Valley Children's Hospital
Madera, California, 93636
- Recruiting
University of Tennessee Health Science Center
Memphis, Tennessee, 38104
- Recruiting
St. Jude Children's Res Hosp
Memphis, Tennessee, 38105
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
Univer South Alabama Ped/Onc
Mobile, Alabama, 36604
- Completed
Northwell Health
Mount Kisco, New York, 10549
- Recruiting
Children's Hosp-New Orleans
New Orleans, Louisiana, 70118
- Recruiting
Newark Beth Israel MC
Newark, New Jersey, 07112-2027
- Recruiting
Children's Hsptl Of The Kings
Norfolk, Virginia, 23507
- Recruiting
Univ of OK Health Sciences Ctr
Oklahoma City, Oklahoma, 73104
- Recruiting
Children's Nebraska
Omaha, Nebraska, 68114
- Completed
University Of California Irvine
Orange, California, 92868
- Recruiting
Stanford University_Palo Alto
Palo Alto, California, 94304
- Recruiting
Children's Hosptl Philadelphia
Philadelphia, Pennsylvania, 19104
- Recruiting
St Christopher Hosp for Child
Philadelphia, Pennsylvania, 19134
- Recruiting
Phoenix Children's Hsptl
Phoenix, Arizona, 85016
- Recruiting
Cohen Children's Medical Ctr
Queens, New York, 11040
- Recruiting
Virginia Comm Univ Medical Ctr
Richmond, Virginia, 23298
- Recruiting
Washington University-St.Louis
St Louis, Missouri, 63110
- Recruiting
Mary Bridge Children's Health
Tacoma, Washington, 98405
- Not yet recruiting
Mary Bridge Children's Health
Tacoma, Washington, 98405
- Recruiting
Jacobi Medical Center
The Bronx, New York, 10461
- Recruiting
Montefiore Medical Ctr
The Bronx, New York, 10467
- Recruiting
Harbor-UCLA Medical Center
Torrance, California, 90502
- Recruiting
Childrens National Medical Ctr
Washington D.C., District of Columbia, 20010
- Recruiting
MedStar Hlth Res Institute
Washington D.C., District of Columbia, 20010
- Recruiting
Nemours/AI duPont Hosp-Chld
Wilmington, Delaware, 19803
- Recruiting
Atrium Health-Wake Forest Bapt
Winston-Salem, North Carolina, 27157
India15 sites, 15 recruiting
- Recruiting
IMS and SUM Hospital
Bhubaneswar, Odisha, 751003
- Recruiting
Zydus Medical College & Hospital
Dohad, Gujarat, 389151
- Recruiting
Gauhati Medical College and Hospital
Guwahati, Assam, 781032
- Recruiting
NIZAM'S Institute of Medical Sciences
Hyderabad, Telangana, 500082
- Recruiting
Government Medical College, Kozhikode
Kozhikode, Kerala, 673008
- Not yet recruiting
Government Medical College, Kozhikode
Kozhikode, Kerala, 673008
- Recruiting
JSS Hospital, Mysore
Mysuru, Karnataka, 570004
- Recruiting
Arihant Multispeciality Hospital
Nagpur, Maharashtra, 440026
- Recruiting
All India Institute of Medical Sciences_New Dehli
New Delhi, 110029
- Recruiting
Post Graduate Institute of Child Health
Noida, Uttar Pradesh, 201303
- Recruiting
All India Institute of Medical Sciences (AIIMS), Raipur
Raipur, Chhattisgarh, 492099
- Recruiting
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, 395002
- Recruiting
RNT Medical College
Udaipur, Rajasthan, 313001
- Recruiting
SSG Hospital, Baroda
Vadodara, Gujarat, 390001
- Recruiting
HOCC Haemato Oncology Care Centre
Vadodara, Gujarat, 390020
Canada11 sites, 10 recruiting
- Recruiting
Foothills Med Ctr-Univ Calgary
Calgary, Alberta, T2N 2T9
- Recruiting
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
- Recruiting
University of Alberta_Edmonton
Edmonton, Alberta, T6G 2B7
- Recruiting
LHSC - Victoria Hospital
London, Ontario, N6A5W9
- Recruiting
CHUM-Hosp de Univ Montreal
Montreal, Quebec, H2X 0C1
- Recruiting
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
- Not yet recruiting
Scarborough Health Network Research Institute (SHNRI)
Scarborough Village, Ontario, M1E 4B9
- Completed
UHN-Toronto General Hospital
Toronto, Ontario, M5G 2C4
- Recruiting
University of Toronto
Toronto, Ontario, M5G1X8
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
- Not yet recruiting
St Pauls Hospital
Vancouver, British Columbia, V6Z 2A5
Italy10 sites, 10 recruiting
- Recruiting
ASST Civili di Brescia
Brescia, 25123
- Recruiting
ARNAS Garibaldi Catania - Presidio Ospedaliero Garibaldi-Centro
Catania, 95123
- Not yet recruiting
Azienda Ospedaliero Universitaria Di Modena - UOC Pediatria ad indirizzo Oncoematologico
Modena, 41100
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
- Recruiting
A.O.U. Università Studi della Campania "Luigi Vanvitelli"
Naples, 80138
- Recruiting
Azienda Ospedaliera Universitaria San Luigi Gonzaga - S.C.D.O. Microcitemie e malattie rare ematologiche
Orbassano, Torino, 10043
- Not yet recruiting
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, Torino, 10043
- Recruiting
Azienda Ospedale Universita Padova
Padova, 35128
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, 90146
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona Policlinico GB Rossi - Borgo Roma - Centro Ricerche Cliniche Di Verona S.r.l.
Verona, Veneto, 37134
Brazil8 sites, 8 recruiting
- Recruiting
Hemocentro UNICAMP
Distrito de Barão Geraldo - Campinas, São Paulo, 13083-878
- Recruiting
MultiHemo - Grupo Oncoclínicas
Recife, Pernambuco, 50070-460
- Not yet recruiting
MultiHemo - Grupo Oncoclínicas
Recife, Pernambuco, 52070-460
- Recruiting
Fundação Hemocentro de Ribeirão Preto
Ribeirão Preto, São, 14051-140
- Recruiting
Hemorio-Fundarj
Rio de Janeiro, 20211-030
- Recruiting
HC da FMUSP Hospital das Clínicas São Paulo
São Paulo, São Paulo, 05403-010
- Not yet recruiting
HC da FMUSP Hospital das Clínicas São Paulo
São Paulo, São Paulo, 05403-010
- Recruiting
Hospital Samaritano Higienópolis - Instituto de Conhecimento Ensino e Pesquisa (ICEP)
São Paulo, 01229-001
Colombia8 sites, 8 recruiting
- Not yet recruiting
Sociedad de Oncología y Hematología del Cesar SAS (SOHEC)
Antioquia, 4006
- Recruiting
Clinica de la Costa
Barranquilla, Atlántico, 80020
- Not yet recruiting
Fundacion Valle del Lili
Cali, Valle del Cauca Department, 760032
- Not yet recruiting
Centro de investigaciones clínicas, fudación valle del lili
Cali, 760032
- Not yet recruiting
Hospital Pablo Tobon Uribe
Medellín, Antioquia, 50034
- Recruiting
Clínica IMAT Oncomedica Auna S.A.S.
Montería, Departamento de Córdoba, 230002
- Not yet recruiting
Clínica IMAT Oncomedica Auna S.A.S.
Montería, 230002
- Recruiting
Sociedad de Oncología y Hematología del Cesar SAS (SOHEC)
Valledupar, Cesar Department, 200001
France8 sites, 8 recruiting
- Not yet recruiting
Ap-Hp-Hopital Avicenne
Bobigny, 93000
- Recruiting
Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
Bordeaux, 33000
- Recruiting
Ap-Hp-Hopital Henri Mondor
Créteil, 94000
- Recruiting
Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon
Grenoble, 38043
- Recruiting
Hospices Civils de Lyon-Hopital Edouard Herriot
Lyon, 69437
- Not yet recruiting
AP-HP-HOPITAL NECKER_Service d'hématologie
Paris, 75015
- Recruiting
Ap-Hp-Hopital Robert Debre
Paris, 75019
- Not yet recruiting
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
Rouen, 76031
Greece8 sites, 8 recruiting
- Recruiting
"Laiko" General Hospital of Athens
Athens, 115 26
- Recruiting
Childrens' Hospital of Athens "Agia Sofia"
Athens, 115 27
- Recruiting
Hippokration Hospital
Athens, 11527
- Not yet recruiting
Hippokration Hospital
Athens, 11527
- Recruiting
University General Hospital Of Ioannina
Ioannina, 45500
- Not yet recruiting
University General Hospital Of Ioannina
Ioannina, 45500
- Recruiting
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki, 546 36
- Not yet recruiting
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki, 546 36
Turkey (Türkiye)8 sites, 8 recruiting
- Recruiting
Acıbadem Adana Hastanesi-Hematoloji
Adana, 01130
- Recruiting
Başkent Üniversitesi Adana-Hematoloji
Adana, 01250
- Recruiting
Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Hematoloji
Adana, 01250
- Recruiting
Hacettepe University Hematology
Ankara, 06230
- Recruiting
Hacettepe Üniversitesi Hastanesi- Hematoloji
Ankara, 06230
- Not yet recruiting
Mersin University Medical Faculty Pediatric Hematology
Mersin, 33110
- Recruiting
Mersin Üniversitesi Tip Fakültesi Hastanesi- Çiftlikköy Yerleşkesi- Hematoloji
Mersin, 33110
- Recruiting
VM Medical Park Mersin Hastanesi- Hematoloji
Mersin, 33200
Belgium6 sites, 6 recruiting
- Recruiting
CHU Saint-Pierre - UMC Sint-Pieter
Brussels, 1000
- Not yet recruiting
CHU - UVC Brugmann
Brussels, 1020
- Recruiting
HUB - Hôpital Erasme
Brussels, 1070
- Recruiting
UZ Antwerpen - UZA - Haematology
Edegem, 2650
- Recruiting
UZ Antwerpen - UZA - Kinderhemato-Oncologie
Edegem, 2650
- Recruiting
UZ Leuven - Kindergeneeskunde
Leuven, 3000
Saudi Arabia6 sites, 6 recruiting
- Not yet recruiting
Al-Moosa Health Group
Al Ahsa, 36342
- Recruiting
King Abdulaziz Hospital-Al Ahsa-National Guard
Al Ahsa, 36428
- Recruiting
Prince Mohammed bin Fahad Hospital for Blood Disorders
Al Qaţīf, 32643
- Recruiting
National Guard Hospital Dammam
Dhahran, 34232
- Recruiting
King Khalid University Hospital
Riyadh, 12372
- Recruiting
King Faisal Specialist Hospital & Research Centre, Riyadh
Riyadh, 12713
United Kingdom6 sites, 6 recruiting
- Recruiting
Addenbrooke's Hospital - Haemophilia and Thrombophilia
Cambridge, CB2 0QQ
- Recruiting
Whittington Hospital
London, N19 5NF
- Recruiting
Guy's Hospital - Haematology
London, SE1 9RT
- Recruiting
King's College Hospital - Paediatric Research
London, SE5 9RS
- Recruiting
Kings College Hospital - Haematology
London, SE5 9RS
- Recruiting
Imperial College London
London, W12 0NN
Spain5 sites, 5 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
- Not yet recruiting
Hospital Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Gregorio Marañón
Madrid, 28009
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
Australia4 sites, 4 recruiting
- Recruiting
Royal Prince Alfred Hospital - Department of Haematology
Camperdown, New South Wales, 2050
- Recruiting
Monash Medical Centre - Haematology Department
Clayton, Victoria, 3168
- Recruiting
Fiona Stanley Hospital - Haemophilia and Haemostasis Centre
Murdoch, Western Australia, 6150
- Recruiting
Prince of Wales Hospital - Department of Haematology
Randwick, New South Wales, 2031
Kenya4 sites, 4 recruiting
- Not yet recruiting
International Cancer Institute (ICI)
Eldoret, Uasin Gishu County, 8088-30100
- Not yet recruiting
Ahero Clinical Trials Unit
Kisumu, 40101
- Not yet recruiting
Gertrude's Children's Hospital
Nairobi, Nairobi County, 00509
- Not yet recruiting
KEMRI CRDR Siaya Clinical Research Annex, Country Referral Hospital
Siaya, Siaya County, 40600
Netherlands4 sites, 4 recruiting
- Recruiting
AmsterdamUMC VUMC
Amsterdam, 1081 HV
- Recruiting
Erasmus MC
Rotterdam, 3015 GD
- Recruiting
HagaZiekenhuis
The Hague, 2545AA
- Recruiting
UMC Utrecht, Van Creveldkliniek
Utrecht, 3584 CX
Nigeria4 sites, 4 recruiting
- Not yet recruiting
Centre of Excellence for Sickle Cell Disease Research and Training, University of Abuja (CESRTA)
Abuja, Federal Capital Territory (fct), 90410
- Not yet recruiting
University College Hospital Paediatric Haematology and Oncology Unit, Ibadan
Ibadan, Oyo State, 0000
- Not yet recruiting
University of Nigeria Teaching Hospital (UNTH)
Ituku-Ozalla, Enugu State, 400001
- Not yet recruiting
Lagos University Teaching Hospital, Lagos
Lagos, 102215
Ghana3 sites, 2 recruiting
- Completed
Agogo Presbyterian Hospital, Ghana
Agogo, 0000
- Not yet recruiting
Kintampo Health Research Centre (KHRC)
Kintampo, Bono East, 27WF+98M
- Not yet recruiting
Navrongo Health Research Centre
Navrongo, Upper East Region, UB-03821
Uganda3 sites, 3 recruiting
- Not yet recruiting
Jinja Regional Referral Hospital
Jinja, Eastern Region, 0000
- Not yet recruiting
Makerere University College of Health Sciences (MakCHS)
Kampala, Central Region, 00000
- Not yet recruiting
Joint Clinical Research Centre (JCRC)
Kampala, Central Region (Wakiso District), 00000
Lebanon2 sites, 2 recruiting
- Recruiting
American University of Beirut Medical Centre
Hamra, 11-0236
- Recruiting
Hospital Nini
Tripoli, 1434
Oman2 sites, 1 recruiting
- Recruiting
Sultan Qaboos University Hospital
Muscat, Sultanet of Oman/Muscat/Al Khoud, 123
- Completed
The Royal Hospital
Muscat, 111
About this study
Official title: A Global Phase 3, Randomised, Double-blind and Placebo-controlled Study Evaluating the Efficacy and Safety of Etavopivat in Adolescents and Adults With Sickle Cell Disease
This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.
- Conditions
- Sickle Cell Disease
- Being tested
- Etavopivat, Placebo
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtavopivatDrug
Etavopivat will be administered orally.
PlaceboDrug
Placebo matching Etavopivat will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Etavopivat | Experimental | Participants will be randomised to receive oral dose of Etavopivat. Receives: Drug: Etavopivat |
| Placebo | Placebo comparator | Participants will be randomised to receive oral dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adjudicated Vaso-occlusive crisis (VOC) events with a medical contact
Measured as Count of events.
Measured: Baseline (week 0) to week 52
Secondary outcomes (10)
Change in Haemoglobin (Hb) greater than 1 grams per decilitre (g/dL)
Measured in Count of participants.
Measured: Baseline (week 0) to week 24
Time to onset of first adjudicated Vaso-occlusive crisis (VOC)
Measured as time in days.
Measured: Baseline (week 0) to week 52
Change in standardised T-score on the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Scale
Measured in T-score.
Measured: Baseline (week 0) to week 52
Change in haemoglobin (Hb)
Measured in grams per decilitre (g/dL).
Measured: Baseline (week 0) to week 52
Change in lactate dehydrogenase (LDH)
Measured in Units per litre (U/L).
Measured: Baseline (week 0) to week 52
Change in absolute reticulocyte count
Measured as Cells x10^9/L.
Measured: Baseline (week 0) to week 52
Change in indirect bilirubin
Measured in milligrams per decilitre (mg/dL).
Measured: Baseline (week 0) to week 52
Change in distance travelled during the 6-minute walking test (6MWT)
Measured in Meters.
Measured: Baseline (week 0) to week 52
Participants achieving the threshold for clinically meaningful change (yes/no) in PROMIS fatigue scale 7a
Measured as Count of participants.
Measured: Baseline (week 0) to week 52
Participants achieving the threshold for clinically meaningful change (yes/no) in 6MWT
Measured as Count of participants.
Measured: Baseline (week 0) to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start17 Feb 2025
- Primary completion27 Aug 2027 (estimated)
- Study completion12 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612268
- Sponsor's protocol ID
- NN7535-7807
- Other IDs
- U1111-1298-3431, 2023-509175-16, 2023
- Acronym
- Hibiscus 2
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2024
- Last updated
- 17 Sep 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