Clinical trial • Phase II • Endocrinology
NISOTIROSTIDE for Type 2 diabetes
Phase II trial of NISOTIROSTIDE for Type 2 diabetes.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 2 diabetes
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 04-04-2025
- First CTIS Authorization Date
- 04-07-2025
Trial design
Nisotirotide (LY3457263) once-weekly subcutaneous (dose not specified) versus placebo to match LY (placebo); background therapy with stable-dose injectable semaglutide or injectable tirzepatide is permitted (participants must be on stable dose for ≥3 months).-controlled Phase II trial across 14 sites in Germany, Poland.
- Comparator
- Nisotirotide (LY3457263) once-weekly subcutaneous (dose not specified) versus placebo to match LY (placebo); background therapy with stable-dose injectable semaglutide or injectable tirzepatide is permitted (participants must be on stable dose for ≥3 months).
- Target Sample Size
- 141
- Trial Duration For Participant
- 168
Eligibility
Recruits 141 Vulnerable population selected (isVulnerablePopulationSelected = true). Specific details on consent/assent handling for vulnerable participants are not provided in the available data..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Specific details on consent/assent handling for vulnerable participants are not provided in the available data.
Inclusion criteria
- {"criterion_text":"- Have type 2 diabetes"}
- {"criterion_text":"- Have overweight or obesity"}
- {"criterion_text":"- Have a stable body weight for three months prior to screening"}
- {"criterion_text":"- Be on a stable dose of injectable semaglutide or injectable tirzepatide for at least three months"}
Exclusion criteria
- {"criterion_text":"- Have type 1 diabetes"}
- {"criterion_text":"- Have taken any medications or alternative remedies for weight loss within three months prior to screening"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from Baseline in Hemoglobin A1c (HbA1c) [Time Frame: Baseline, Week 24]","definition_or_measurement_approach":"Change from baseline in Hemoglobin A1c (HbA1c) measured at Baseline and Week 24 (time frame: Baseline, Week 24)."}
Recruitment
- Digital Remote Recruitment
- True, methods include Trialbee digital marketing content and Trialbee landing page, digital recruitment materials and online landing pages as specified in recruitment documents.
- Planned Sample Size
- 141
- Recruitment Window Months
- 17
- Consent Approach
- Informed consent will be obtained using subject information and informed consent form documents (multiple ICF and subject information documents listed, including language-specific versions such as Polish ICFs). There is also an ICF for pregnant partners. Specific details on who provides consent/assent (e.g., age-based assent) are not described in the provided data.
Methods
- Trialbee digital recruitment (Trialbee materials and Trialbee landing page referenced in recruitment documents)
- Digital marketing content (document: K2_Recruitment material_Digital Marketing Content)
- Flyers, Posters, Brochures (K2_Recruitment material_Flyer, Poster, Brochure documents)
- Doctor-to-patient letter / Doctor referral (K2_Recruitment material_Letter-Doctor-Referral; K2_Recruitment material_Letter Doctor to Patient)
- Clinical trial recruitment vendors/agencies (Reify Health Inc., Clinical Trial Media Inc., Trialbee AB listed with recruiting responsibilities)
- Site-based recruitment via participating clinical sites (local site contacts listed for Germany and Poland)
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 59
Germany
- Earliest CTIS Part Ii Submission Date
- 30-06-2025
- Latest Decision Or Authorization Date
- 14-10-2025
- Processing Time Days
- 106
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
- Principal Investigator Name
- Thomas Schaum
- Principal Investigator Email
- schaum@red-institut.de
- Contact Person Name
- Thomas Schaum
- Contact Person Email
- schaum@red-institut.de
- Site Name
- Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
- Principal Investigator Name
- Heidrun Taeschner
- Principal Investigator Email
- dr.taeschner@web.de
- Contact Person Name
- Heidrun Taeschner
- Contact Person Email
- dr.taeschner@web.de
- Site Name
- InnoDiab Forschung GmbH
- Principal Investigator Name
- Helga Zeller
- Principal Investigator Email
- helga.zeller@innodiab.de
- Contact Person Name
- Helga Zeller
- Contact Person Email
- helga.zeller@innodiab.de
- Site Name
- Institut fuer Diabetesforschung Muenster GmbH
- Principal Investigator Name
- Ludger Rose
- Principal Investigator Email
- l.rose@diabetes-muenster.de
- Contact Person Name
- Ludger Rose
- Contact Person Email
- l.rose@diabetes-muenster.de
- Site Name
- Velocity Clinical Research Leipzig
- Principal Investigator Name
- Thomas Müller
- Principal Investigator Email
- tmueller@velocityclinical.com
- Contact Person Name
- Thomas Müller
- Contact Person Email
- tmueller@velocityclinical.com
Poland
- Earliest CTIS Part Ii Submission Date
- 04-07-2025
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 144
- Number Of Sites
- 9
- Number Of Participants
- 39
Sites
- Site Name
- Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
- Department Name
- -
- Principal Investigator Name
- Joanna Mirocka
- Principal Investigator Email
- jmirocka@gmail.com
- Contact Person Name
- Joanna Mirocka
- Contact Person Email
- jmirocka@gmail.com
- Site Name
- Ekamed Sp. z o.o.
- Department Name
- -
- Principal Investigator Name
- Ewa Skokowska
- Principal Investigator Email
- skokowska@onet.pl
- Contact Person Name
- Ewa Skokowska
- Contact Person Email
- skokowska@onet.pl
- Site Name
- Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
- Department Name
- -
- Principal Investigator Name
- Małgorzata Józefowska
- Principal Investigator Email
- m.jozefowska@ctw.com.pl
- Contact Person Name
- Małgorzata Józefowska
- Contact Person Email
- m.jozefowska@ctw.com.pl
- Site Name
- Centrum Badan Klinicznych Pi-House Sp. z o.o.
- Department Name
- -
- Principal Investigator Name
- Monika Lukaszewicz
- Principal Investigator Email
- m.lukaszewicz@pihouse.pl
- Contact Person Name
- Monika Lukaszewicz
- Contact Person Email
- m.lukaszewicz@pihouse.pl
- Site Name
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
- Department Name
- Centrum Wsparcia Badan Klinicznych
- Principal Investigator Name
- Mateusz Tabin
- Principal Investigator Email
- tabin.kliniczne@gmail.com
- Contact Person Name
- Mateusz Tabin
- Contact Person Email
- tabin.kliniczne@gmail.com
- Site Name
- Szpital Czerniakowski Sp. z o.o.
- Department Name
- -
- Principal Investigator Name
- Olga Turowska
- Principal Investigator Email
- olga.turowska@gmail.com
- Contact Person Name
- Olga Turowska
- Contact Person Email
- olga.turowska@gmail.com
- Site Name
- NBR Polska
- Department Name
- -
- Principal Investigator Name
- Katarzyna Kłodawska
- Principal Investigator Email
- katarzyna.klodawska@nbrpolska.pl
- Contact Person Name
- Katarzyna Kłodawska
- Contact Person Email
- katarzyna.klodawska@nbrpolska.pl
- Site Name
- Legeartis Poradnie Specjalistyczne Sp. z o.o.
- Department Name
- -
- Principal Investigator Name
- Anna Modzelewska
- Principal Investigator Email
- anamed@onet.eu
- Contact Person Name
- Anna Modzelewska
- Contact Person Email
- anamed@onet.eu
- Site Name
- Ośrodek Badań Klinicznych "METABOLICA" Lek. Robert Witek
- Department Name
- Ośrodek Badań Klinicznych METABOLICA Lek. Robert Witek
- Principal Investigator Name
- Robert Witek
- Principal Investigator Email
- robertwitek1@gmail.com
- Contact Person Name
- Robert Witek
- Contact Person Email
- robertwitek1@gmail.com
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Iqvia Biotech LLC
- Responsibilities
- sponsorDuties code: 1
- Name
- Q2 Solutions LLC
- Responsibilities
- Laboratory/Testing services (sponsorDuties code: 4)
Third parties
- {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Q2 Solutions","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Health care"}
- {"country":"United States","full_name":"The Hibbert Co.","duties_or_roles":"Distribution of study materials (sponsorDuties code: 15)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties code: 2","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Health care"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"translation (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"sponsorDuties code: 13","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Tier 1 Impact Pbc Inc.","duties_or_roles":"Study Training (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"recruiting (sponsorDuties code: 15)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Sweden","full_name":"Trialbee AB","duties_or_roles":"recruiting (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"recruiting (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"shipment of supplies (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Nisotirotide (LY3457263)
- Active Substance
- NISOTIROSTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Frequency
- Once weekly
- Investigational Product Name
- placebo to match LY
- Modality
- Other
- Investigational Product Name
- Tirzepatide (background therapy auxiliary)
- Active Substance
- TIRZEPATIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Frequency
- Stable injectable background therapy (dose as per participant's current regimen)
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.