Clinical trial • Phase III • Cardiology

SOTAGLIFLOZIN for Obstructive hypertrophic cardiomyopathy | Non-obstructive hypertrophic cardiomyopathy

Phase III trial of SOTAGLIFLOZIN for Obstructive hypertrophic cardiomyopathy | Non-obstructive hypertrophic cardiomyopathy.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Obstructive hypertrophic cardiomyopathy | Non-obstructive hypertrophic cardiomyopathy
Trial Stage
Phase III
Drug Modality
Small molecule | Other

Key dates

Initial CTIS Submission Date
06-09-2024
First CTIS Authorization Date
15-01-2025

Trial design

Randomised, placebo — two tablets taken orally once daily (matching sotagliflozin); sotagliflozin — two 200-mg tablets taken orally once daily-controlled Phase III trial in Poland, Germany, Portugal and others.

Randomised
Yes
Comparator
Placebo — two tablets taken orally once daily (matching sotagliflozin); Sotagliflozin — two 200-mg tablets taken orally once daily
Target Sample Size
229
Trial Duration For Participant
210

Eligibility

Recruits 229 isVulnerablePopulationSelected is true. Subject information and informed consent forms (L1_SIS and ICF) include specific versions for pregnant participants and pregnant partners and optional research consents; country-specific ICFs and language versions are provided. Consent is obtained using the provided subject information and informed consent forms..

Vulnerable Population
isVulnerablePopulationSelected is true. Subject information and informed consent forms (L1_SIS and ICF) include specific versions for pregnant participants and pregnant partners and optional research consents; country-specific ICFs and language versions are provided. Consent is obtained using the provided subject information and informed consent forms.

Inclusion criteria

  • {"criterion_text":"- KCCQ CSS < 85.\n- NYHA functional class II or III\n- A diagnosis of HCM consistent with the current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guideline definition: unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (eg, hypertension, aortic stenosis) or systemic disease with maximal LV wall thickness ≥ 15 millimeters (mm), or ≥ 13 mm with positive family history of HCM.\n- For obstructive hypertrophic cardiomyopathy (oHCM), left ventricular outflow tract (LVOT) peak gradient ≥ 30 millimetre of mercury (mm Hg) during screening as assessed by echocardiography at rest or during a valsalva maneuver.\n- For nonobstructive hypertrophic cardiomyopathy (nHCM), LVOT peak gradient < 30 mm Hg during screening as assessed by echocardiography at rest and < 30 mm Hg during a valsalva maneuver.\n- Screening left ventricular ejection fraction (LVEF) ≥ 50%, except for those on a cardiac myosin inhibitor (screening LVEF ≥ 55%).\n- For participants on a cardiac myosin inhibitor, the dose must be stable at least 3 months prior to screening. Participants on cardiac myosin inhibitor should not be scheduled for up-titration during the trial.\n- Stable doses of background therapy (ie, β-blockers, calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, diuretics) for at least 1 month prior to screening."}

Exclusion criteria

  • {"criterion_text":"- Received therapy with a sodium glucose co-transporter 2 (SGLT2) inhibitor within the past 8 weeks prior to screening.\n- Septal reduction therapy planned during the study period. For participants who had septal reduction therapy, the procedure should have been completed more than 3 months prior to screening.\n- Cardiac surgery (eg, coronary artery bypass graft, valvular repair/replacement), percutaneous coronary intervention, or implantation of cardiac device (pacemaker or implantable cardioverter defibrillator) within 3 months prior to screening or planned during the study period.\n- Presence of a cardiac resynchronization therapy device.\n- Acute coronary syndrome within 2 months prior to screening.\n- History of stroke or myocardial infarction within 6 months prior to screening.\n- Hospitalization for heart failure or arrhythmia within 4 weeks prior to screening.\n- Has known moderate or severe (as per investigator's judgment) aortic valve stenosis at screening.\n- Current angina or clinically significant ischemia due to unstable epicardial coronary disease, as per investigator judgment.\n- Previous intolerance to an SGLT2 inhibitor.\n- Any previous treatment with sotagliflozin.\n- Current use of thiazolidinediones or digoxin.\n- Current/planned participation in another interventional clinical trial or prior participation in any interventional trial with an investigational agent within 45 days of screening.\n- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.\n- History of unexplained syncope within 6 months prior to screening.\n- History of sustained ventricular tachyarrhythmia (> 30 seconds) or appropriate ICD (implantable cardioverter defibrillator) discharge within the 6 months prior to Screening.\n- Has paroxysmal, persistent, or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to screening and/or not adequately rate controlled within 3 months of screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS).","definition_or_measurement_approach":"Change from baseline to Week 26 assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of patients at Week 26 with a New York Heart Association (NYHA) functional class improvement ≥ 1 category","definition_or_measurement_approach":"Proportion of patients at Week 26 with ≥1-category improvement in NYHA functional class."}
  • {"endpoint_text":"- Change from Baseline to Week 26 in KCCQ Total Symptom Score (TSS)","definition_or_measurement_approach":"Change from baseline to Week 26 assessed using the KCCQ Total Symptom Score (TSS)."}
  • {"endpoint_text":"- Treatment-emergent adverse events (TEAEs) reported during the double-blind treatment period and through Week 30.","definition_or_measurement_approach":"All treatment-emergent adverse events collected/reported during the double-blind treatment period and through Week 30."}
  • {"endpoint_text":"- Clinical laboratory results (including serum creatinine and estimated glomerular filtration rate [eGFR]) and vital signs through Week 26.","definition_or_measurement_approach":"Clinical laboratory measures (including serum creatinine and eGFR) and vital signs collected through Week 26."}
  • {"endpoint_text":"- Change from Baseline at Week 4 and Week 26 in left ventricular outflow tract (LVOT) gradient (at rest and with Valsalva maneuver) as measured by echocardiogram.","definition_or_measurement_approach":"Change from baseline to Week 4 and Week 26 in LVOT peak gradient measured by echocardiography at rest and with Valsalva maneuver."}

Recruitment

Digital Remote Recruitment
True, recruitment materials include video scripts, study overview videos and adverts intended for digital dissemination; study brochures and materials provided in electronic formats and multiple languages to support remote/digital recruitment.
Planned Sample Size
229
Recruitment Window Months
21
Consent Approach
Informed consent is obtained using subject information sheets and informed consent forms (L1_SIS and ICF). Country-specific and language-specific ICFs are provided (multiple versions found: EN, FR, DE, NL, PT, ES, CZ, HU, PL, SE, RO, BG, HR, IT). Specific ICFs exist for pregnant participants and pregnant partners and optional research consents; consent is therefore obtained from the adult participant via the provided ICF documents.

Methods

  • Patient brochure — printed/ PDF information materials for potential participants (country-specific translations available: e.g., PL, DE, PT, HR, CZ, EN, FR, NL, HU, SE, ES, IT, BG, RO).
  • Letter to patient — invitation/cover letters for potential participants (country-specific).
  • Video script / Study overview video — audiovisual recruitment material (Study overview video and country-specific video scripts present).
  • GP/clinician letter — letters to general practitioners/clinicians to inform and refer eligible patients.
  • Database letter — outreach via clinical/databases (database letter documents present).
  • Patient ID card / Patient alert card — short printed card for enrolled patients.
  • Advert — study adverts (e.g., K3_SONATA Advert_SE_SWE) for public outreach.

Geography

Total Number Of Sites
63
Total Number Of Participants
271

Poland

Earliest CTIS Part Ii Submission Date
18-12-2024
Latest Decision Or Authorization Date
21-01-2025
Processing Time Days
34
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
Medicome Sp. z o.o.
Contact Person Name
Iwona Kobielusz-Gembala
Contact Person Email
iwonagembala@wp.pl
Site Name
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Department Name
Klinika Kardiologii, Ośrodek Chorób Serca
Contact Person Name
Bartosz Krakowiak
Contact Person Email
bartek.krakowiak@gmail.com
Site Name
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
Department Name
Oddział Kardiologiczny Klinika Kardiologii Katedry Kardiologii UM w Łodzi
Contact Person Name
Radosław Kręcki
Contact Person Email
rkrecki@gmail.com
Site Name
Umed Clinical Trials Sp. z o.o.
Contact Person Name
Jarosław Drożdż
Contact Person Email
jaroslaw.drozdz@umed.pl

Germany

Earliest CTIS Part Ii Submission Date
13-11-2024
Latest Decision Or Authorization Date
20-01-2025
Processing Time Days
68
Number Of Sites
4
Number Of Participants
22

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Kardiologie, Angiologie und Intensivmedizin
Contact Person Name
Frank Edelmann
Contact Person Email
frank.edelmann@charite.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinischen Klinik und Poliklinik I - Kardiologie
Contact Person Name
Stefan Brunner
Site Name
Cardiologicum Hamburg GbR
Department Name
Studienzentrum
Contact Person Name
Martin Bergmann
Contact Person Email
m.bergmann@cardiologicum.net
Site Name
Herzzentrum Leipzig GmbH
Department Name
Klinik fuer Innere Medizin/Kardiologie
Contact Person Name
Steffen Desch

Portugal

Earliest CTIS Part Ii Submission Date
28-11-2024
Latest Decision Or Authorization Date
20-01-2025
Processing Time Days
53
Number Of Sites
9
Number Of Participants
26

Sites

Site Name
Hospital Cuf Tejo S.A.
Department Name
Cardiologia
Contact Person Name
João Agostinho
Contact Person Email
joao.agostinho@cuf.pt
Site Name
Hospital Cuf Descobertas S.A.
Department Name
Cardiologia
Contact Person Name
Rui Guerreiro
Contact Person Email
rui.a.guerreiro@cuf.pt
Site Name
Hospital Da Luz S.A.
Department Name
Cardiologia
Contact Person Name
Alexandra Toste
Contact Person Email
atoste@hospitaldaluz.pt
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Cardiologia
Contact Person Name
Filipa Cordeiro
Contact Person Email
filipabritocordeiro@gmail.com
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Cardiologia
Contact Person Name
Carlos Aguiar
Contact Person Email
ctaguiar@hotmail.com
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Cardiologia
Contact Person Name
Dulce Brito
Contact Person Email
dulcebrito59@gmail.com
Site Name
Unidade Local de Saude do Algarve E.P.E.
Department Name
Cardiologia
Contact Person Name
Dina Bento
Contact Person Email
dinabento@gmail.com
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Cardiologia
Contact Person Name
Elisabete Martins
Contact Person Email
elisabetemartins09@gmail.com
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Cardiologia
Contact Person Name
Cátia Oliveira
Contact Person Email
catia.oliveira@hb.min-saude.pt

Croatia

Earliest CTIS Part Ii Submission Date
07-01-2025
Latest Decision Or Authorization Date
21-01-2025
Processing Time Days
14
Number Of Sites
4
Number Of Participants
28

Sites

Site Name
MAGDALENA klinika za kardiovaskularne bolesti Medicinskog fakulteta Sveucilista J.J. Strossmayera u Osijeku
Department Name
Cardiology department
Contact Person Name
Luka Rotkvić
Contact Person Email
lukaro_1999@yahoo.com
Site Name
Clinical Hospital Centre Rijeka
Department Name
Clinic for heart and blood vessel disease
Contact Person Name
Koraljka Benko
Contact Person Email
bkoraljka@yahoo.com
Site Name
Klinicki bolnicki centar Sestre milosrdnice
Department Name
Department for cardiomyopathies, heart failure and heart valve diseases
Contact Person Name
Matias Trbušić
Contact Person Email
matias.trbusic@gmail.com
Site Name
Thalassotherapia Specijalna bolnica za medicinsku rehabilitaciju bolesti srca pluca i reumatizma
Department Name
Cardiology department
Contact Person Name
Viktor Peršić
Contact Person Email
viktor.persic@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
19-12-2024
Latest Decision Or Authorization Date
16-01-2025
Processing Time Days
28
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Krajska zdravotni a.s.
Department Name
Kardiologická klinika
Contact Person Name
Nedal Omran
Contact Person Email
nedal.omran@kzcr.eu
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
I. internikardioangiologicka klinika
Contact Person Name
Tomáš Honek
Contact Person Email
tomas.honek@fnusa.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
II. Interni klinika – klinika kardiologie a angiologie
Contact Person Name
David Zemánek
Contact Person Email
david.zemanek@vfn.cz

Belgium

Earliest CTIS Part Ii Submission Date
28-11-2024
Latest Decision Or Authorization Date
16-01-2025
Processing Time Days
49
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Ziekenhuis Oost Limburg
Department Name
Cardiology
Contact Person Name
Matthias Dupont
Contact Person Email
matthias.dupont@zol.be
Site Name
Onze-Lieve-Vrouwziekenhuis
Department Name
Cardiology
Contact Person Name
Jozef Bartunek
Contact Person Email
jozef.bartunek@olv-aalst.be
Site Name
Hopital Erasme
Department Name
Cardiology
Contact Person Name
Antoine Bondue
Contact Person Email
antoine.bondue@hubruxelles.be

France

Earliest CTIS Part Ii Submission Date
27-11-2024
Latest Decision Or Authorization Date
16-01-2025
Processing Time Days
50
Number Of Sites
7
Number Of Participants
28

Sites

Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Cardiology
Contact Person Name
Anne Bernard
Contact Person Email
anne.bernard@univ-tours.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Cardiology
Contact Person Name
Philippe Charron
Contact Person Email
philippe.charron@aphp.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Cardiology
Contact Person Name
Gilbert Habib
Contact Person Email
gilbert.habib@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Cardiology
Contact Person Name
Erwan Donal
Contact Person Email
erwan.donal@chu-rennes.fr
Site Name
Centre Hospitalier Regional De Marseille (duplicate listing addressed above)
Department Name
Cardiology
Contact Person Name
Claire BOULETI
Contact Person Email
Claire.BOULETI@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Cardiology
Contact Person Name
Eve Cariou
Contact Person Email
cariou.e@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Cardiology
Contact Person Name
Claire BOULETI
Contact Person Email
Claire.BOULETI@chu-poitiers.fr

Romania

Earliest CTIS Part Ii Submission Date
03-12-2024
Latest Decision Or Authorization Date
21-01-2025
Processing Time Days
49
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Cardio Med S.R.L.
Department Name
Cardiology
Contact Person Name
Imre Sandor Benedek
Contact Person Email
imrebenedek@yahoo.com
Site Name
CMI Dr. Podoleanu Cristian
Department Name
Cardiology
Contact Person Name
Cristian-Gheorghe-Calin Podoleanu
Contact Person Email
podoleanu@me.com
Site Name
U 2 Serv Com S.R.L.
Department Name
Cardiology
Contact Person Name
Titel-Razvan Cojocariu
Contact Person Email
cojotit@yahoo.com
Site Name
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Department Name
Cardiology
Contact Person Name
Andrei-Mihnea Rosu
Contact Person Email
rosuandreimihnea@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
20-01-2025
Processing Time Days
117
Number Of Sites
5
Number Of Participants
23

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Cardiology
Contact Person Name
Marianna Adamo
Site Name
Policlinico San Donato S.p.A.
Department Name
Cardiology
Contact Person Name
Massimo Piepoli
Contact Person Email
Massimo.Piepoli@unimi.it
Site Name
Azienda Unita' Sanitaria Locale Toscana Sud Est
Department Name
Cardio Toraco Neurovascolare
Contact Person Name
Michele Ciabatti
Contact Person Email
michele.ciabatti1989@gmail.com
Site Name
Careggi University Hospital
Department Name
Cardiology
Contact Person Name
Iacopo Olivotto
Contact Person Email
iacopo.olivotto@unifi.it
Site Name
Azienda Ospedaliera Dei Colli
Department Name
Scienze Mediche Traslazionali
Contact Person Name
Giuseppe Limongelli

Bulgaria

Earliest CTIS Part Ii Submission Date
28-11-2024
Latest Decision Or Authorization Date
21-01-2025
Processing Time Days
54
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Multiprofile Hospital For Active Treatment Medical Complex Sveti Ivan Rilski EOOD
Department Name
Department of Cardiology
Contact Person Name
Krastyu Penchev
Contact Person Email
k11081964@yahoo.com
Site Name
Tokuda Hospital
Department Name
Clinic of cardiology
Contact Person Name
Valeri Gelev
Contact Person Email
vgelev@abv.bg
Site Name
Specialized Hospital For Active Cardiology Treatment Medica Kor EAD
Department Name
Department of Cardiology
Contact Person Name
Dobrin Vassilev
Contact Person Email
dobrinv@gmail.com
Site Name
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
Department Name
First Cardiology Clinic
Contact Person Name
Ivo Petrov
Contact Person Email
petrovivo@hotmail.com

Hungary

Earliest CTIS Part Ii Submission Date
05-11-2024
Latest Decision Or Authorization Date
17-01-2025
Processing Time Days
73
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
University Of Szeged
Department Name
Cardiology
Contact Person Name
Róbert Sepp
Contact Person Email
sepprobert@gmail.com
Site Name
Zala Varmegyei Szent Rafael Korhaz
Department Name
Cardiology
Contact Person Name
Géza Lupkovics
Contact Person Email
lupkogeza@t-online.hu
Site Name
Semmelweis University
Department Name
Cardiology
Contact Person Name
Béla Merkely
Contact Person Email
merkely.study@gmail.com
Site Name
University Of Pecs
Department Name
Cardiology
Contact Person Name
Réka Faludi
Contact Person Email
faludi.reka@pte.hu

Sweden

Earliest CTIS Part Ii Submission Date
02-12-2024
Latest Decision Or Authorization Date
17-01-2025
Processing Time Days
46
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Karolinska University Hospital
Department Name
Cardiology
Contact Person Name
Lars Lund
Contact Person Email
lars.lund@alumni.duke.edu
Site Name
Akardo AB
Contact Person Name
Åke Olsson
Contact Person Email
ake.olsson@akardomedsite.se

Spain

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
15-01-2025
Processing Time Days
112
Number Of Sites
10
Number Of Participants
36

Sites

Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Cardiology
Contact Person Name
Pablo Garcia Pavia
Contact Person Email
pablogpavia@yahoo.es
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Cardiology
Contact Person Name
Vicente Eduardo Climent Paya
Contact Person Email
vcliment@coma.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Cardiology
Contact Person Name
Roberto Barriales Villa
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Cardiology
Contact Person Name
Juan Ramon Gimeno Blanes
Contact Person Email
jgimeno@secardiologia.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Cardiology
Contact Person Name
Julio Nuñez Villota
Contact Person Email
juenuvi@uv.es
Site Name
Hospital Clinic De Barcelona
Department Name
Cardiology
Contact Person Name
Ana Garcia Alvarez
Contact Person Email
anagarci@clinic.cat
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Cardiology
Contact Person Name
Jose Manuel Garcia Pinilla
Contact Person Email
marlucale41@gmail.com
Site Name
Hospital Son Llatzer
Department Name
Cardiology
Contact Person Name
Jorge Alvarez Rubio
Contact Person Email
ialvarezr@hsll.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Cardiology
Contact Person Name
Rafael Hidalgo Urbano
Contact Person Email
rjhidalur@yahoo.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Cardiology
Contact Person Name
Maria Alvarez Barredo
Contact Person Email
mariaalvarezba@hotmail.com

Sponsor

Primary sponsor

Full Name
Lexicon Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PCI Pharma Services Germany GmbH
Responsibilities
sponsorDuties code: 14
Name
Fortrea Inc.
Responsibilities
multiple sponsorDuties including IRT (RTSM build) and clinical operations-related roles (codes: 1,2,5,8,10,12,13,15)
Name
Scarritt Group Inc.
Responsibilities
Patient reimbursement (sponsorDuties code 15)
Name
Biotel Research LLC
Responsibilities
Medical imaging (sponsorDuties code 15)
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central laboratory services (sponsorDuties code 4)

Third parties

  • {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 3, 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: 1, 10, 12, 13, 15 (IRT (RTSM build)), 2, 5, 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scarritt Group Inc.","duties_or_roles":"sponsorDuties code: 15 (Patient reimbursement)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Biotel Research LLC","duties_or_roles":"sponsorDuties code: 15 (Medical imaging)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
SOTAGLIFLOZIN
Active Substance
SOTAGLIFLOZIN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorisation withdrawn in 2022.
Starting Dose
400 mg (two 200-mg tablets once daily)
Dose Levels
200 mg tablets, two tablets once daily (total 400 mg)
Frequency
once daily
Maximum Dose
400 mg
Investigational Product Name
PLACEBO SOTAGLIFLOZIN
Modality
Other
Route
oral
Starting Dose
Two tablets taken orally once daily (matching sotagliflozin)
Dose Levels
Two tablets once daily (matching active formulation)
Frequency
once daily

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