A Research Study Investigating How Well Zenagamtide Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease Treated With Once Daily Basal Insulin Alone or in Combination With Metformin, SGLT2i, or Both (AMBITION 2)
Efficacy and Safety of Zenagamtide s.c. Once Weekly Compared to Placebo in Participants With Type 2 Diabetes and Chronic Kidney Disease Inadequately Controlled on Once Daily Basal Insulin Alone or in Combination With Metformin, SGLT2i, or Both
The study is testing zenagamtide in participants with type 2 diabetes and chronic kidney disease. The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have type 2 diabetes. Participants will either get zenagamtide or placebo. Which treatment participants get is decided by chance. Zenagamtide is a new medicine that doctors cannot prescribe yet, but it has been tested in humans before.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Faza 3
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Novo Nordisk
- Numer telefonu: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Lokalizacje studiów
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazylia, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
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Porto Alegre, Rio Grande do Sul, Brazylia, 90035-903
- Hospital de Clínicas de Porto Alegre_Porto Alegre
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São Paulo
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Campinas, São Paulo, Brazylia, 13060-080
- Instituto de Pesquisa Clínica de Campinas
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São Paulo, São Paulo, Brazylia, 01228-000
- CPQuali Pesquisa Clínica Ltda
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-
-
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Anhui
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Hefei, Anhui, Chiny, 230012
- The Second People's Hospital of Hefei-Endocrinology
-
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Chongqing Municipality
-
Chongqing, Chongqing Municipality, Chiny, 404199
- Chongqing University Three Gorges Hospital-Endocrinology
-
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Guangdong
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Huizhou, Guangdong, Chiny, 516001
- Huizhou Central People's Hospital-Endocrinology
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Shenzhen, Guangdong, Chiny, 518035
- The Second People's Hospital of Shenzhen-Endocrinology
-
-
Hebei
-
Hengshui, Hebei, Chiny, 053000
- Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
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Shijiazhuang, Hebei, Chiny, 050000
- The Second Hospital of Hebei Medical University-Endocrinology
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Henan
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Kaifeng, Henan, Chiny, 475000
- Huaihe Hospital of Henan University-Endocrinology
-
Luoyang, Henan, Chiny, 471003
- The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
-
Luoyang, Henan, Chiny, 471002
- Luoyang First People's Hospital-Endocrinology
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Nanyang, Henan, Chiny, 473058
- The First Affiliated Hospital of Nanyang Medical College-Endocrinology
-
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Hunan
-
Changde, Hunan, Chiny, 415003
- The First People's Hospital of Changde City-Endocrinology
-
-
Jiangsu
-
Changzhou, Jiangsu, Chiny, 213004
- The First People's Hospital of Changzhou-Endocrinology
-
Nanjing, Jiangsu, Chiny, 210011
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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Zhenjiang, Jiangsu, Chiny, 212001
- The Affiliated Hospital of Jiangsu University-Endocrinology
-
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Jilin
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Jilin City, Jilin, Chiny, 130041
- The Second Norman Bethune Hospital of Jilin University-Endocrinology
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Shandong
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Jinan, Shandong, Chiny, 250013
- Jinan Central Hospital-General Medicine
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chiny, 201200
- Shanghai Pudong New Area People's Hospital-Endocrinology
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Sichuan
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Chengdu, Sichuan, Chiny, 610071
- Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Endocrinology
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Chiny, 300070
- Tianjin Medical University Chu Hsien-I Memorial Hospital-Endocrinology
-
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Zhejiang
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Huzhou, Zhejiang, Chiny, 313000
- Huzhou Central Hospital-Endocrinology
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-
-
-
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Chrudim III, Czechy, 53701
- INTENDIA klinika s.r.o.
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Prague, Czechy, 150 00
- EUC Klinika Praha a.s.
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Prague, Czechy, 10400
- ENDOTRIAL s.r.o.
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Prague, Czechy, 140 00
- Medicon a.s.
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Prague, Czechy, 149 00
- Milan Kvapil s.r.o.
-
Prague, Czechy, 160 00
- Fledip s.r.o.
-
Prague, Czechy, 190 00
- DiaIn s.r.o.
-
Praha Klanovice, Czechy, 190 14
- TreDia s.r.o.
-
-
-
-
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New Delhi, Indie, 110029
- All India Institute of Medical Sciences (AIIMS)
-
-
Andhra Pradesh
-
Guntur, Andhra Pradesh, Indie, 522001
- Endolife Specialty Hospitals
-
-
Chhattisgarh
-
Raipur, Chhattisgarh, Indie, 492099
- All India Institute of Medical Sciences (AIIMS), Raipur
-
-
Gujarat
-
Vadodara, Gujarat, Indie, 390001
- SSG Hospital, Baroda
-
-
Karnataka
-
Bangalore, Karnataka, Indie, 560092
- Life Care Hospital and Research Centre
-
-
Kerala
-
Kozhikode, Kerala, Indie, 673008
- Government Medical College, Kozhikode
-
-
Maharashtra
-
Kohlapur, Maharashtra, Indie, 416001
- Shree Mahalaxmi DIATONE Institute
-
Kolhāpur, Maharashtra, Indie, 416008
- Excel Endocrine Centre
-
Pune, Maharashtra, Indie, 411002
- Shree Samarth Hospital
-
-
Punjab
-
Ludhiana, Punjab, Indie, 141001
- Dayanand Medical College & Hospital
-
-
Rajasthan
-
Jaipur, Rajasthan, Indie, 302004
- SMS Medical College & Hospital
-
-
Tamil Nadu
-
Vellore, Tamil Nadu, Indie, 632004
- Christian Medical College Hospital, Vellore
-
-
Telangana
-
Hyderabad, Telangana, Indie, 500082
- NIZAM'S Institute of Medical Sciences
-
-
-
-
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Aichi, Japonia, 468-0009
- TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
-
Arakawa-ku, Tokyo, Japonia, 116-0012
- Kumanomae Nishimura Naika Clinic_Internal Medicine
-
Chiba-shi, Chiba, Japonia, 260-0804
- Akaicho Clinic_Internal medicine
-
Chikushino-shi, Fukuoka, Japonia, 818-0024
- Ito Naika Clinic_Internal Medicine and Diabetology
-
Gifu, Japonia, 501-1194
- Gifu University Hospital_Diabetes and Endocrinology
-
Ibaraki, Japonia, 311-0113
- Naka Kinen Clinic_Internal medicine
-
Kamakura-shi, Kanagawa, Japonia, 247 0072
- Shonan Kamakura General Hospital_Diabetes and Endocrinology
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Koriyama-shi, Fukushima, Japonia, 963-8851
- Seino Internal Medicine Clinic_Internal medicine
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Minato-ku, Tokyo, Japonia, 105-8471
- The Jikei University Hospital_Diabetes, Metabolism, Endocrinology
-
Mito-shi, Ibaraki, Japonia, 311-4153
- Minami Akatsuka Clinic_internal medicine
-
Sendai, Miyagi, Japonia, 981-8563
- Tohoku Rosai Hospital_Diabetes, Endocrinology and Hypertension
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Tamana-shi, Kumamoto, Japonia, 865-0016
- Higashi Diabetes and Cardiovascular Clinic_Diabetes internal medicine, Cardiology
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Tokyo, Japonia, 103-0027
- Tokyo-Eki Center-building Clinic_Internal Medicine
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Tokyo, Japonia, 104-0031
- Fukuwa Clinic_Internal Medicine
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Tsu-shi, Mie, Japonia, 514-1101
- Mie Chuo Medical Center_Department of Diabetes and Endocrinology
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Wakayama, Japonia, 640-8558
- Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology
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Japan
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Oita-shi, Oita,, Japan, Japonia, 870 0039
- Abe Diabetes Clinic_Internal Medicine
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Gwangju, Korea Południowa, 61453
- Chosun University Hospital_Endocrinology
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Seoul, Korea Południowa, 01830
- Nowon Eulji Medical Center, Eulji University_Endocrinology
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Seoul, Korea Południowa, 03181
- Kangbuk Samsung Hospital_Endocrinology
-
Seoul, Korea Południowa, 03080
- Seoul National University Hospital_Endocrinology
-
Seoul, Korea Południowa, 03722
- Severance Hospital, Yonsei University Health System_Endocrinology
-
Seoul, Korea Południowa, 06591
- The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology
-
Seoul, Korea Południowa, 02841
- Korea University Anam Hospital_Endocrinology
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Seoul, Korea Południowa, 04763
- Hanyang University Seoul Hospital_Endocrinology
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Gangwon-do
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Wŏnju, Gangwon-do, Korea Południowa, 26426
- Wonju Severance Christian Hospital_Endocrinology
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Gyeonggi-do
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Bucheon-si, Gyeonggi-do, Korea Południowa, 14647
- The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
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Bad Mergentheim, Niemcy, 97980
- Diabetespraxis Mergentheim
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Berlin, Niemcy, 13597
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
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Ludwigshafen, Niemcy, 67059
- Die Praxis am Ludwigsplatz
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Mainz, Niemcy, 55116
- Gesundheitscentrum Mainz (Regner / Schmitt)
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Münster, Niemcy, 48153
- MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
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Pirna, Niemcy, 01796
- Hausärztliche und Diabetologische Praxis Pirna
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Pohlheim, Niemcy, 35415
- ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
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Gdansk, Polska, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Gmina Świecie, Polska, 86-100
- Nowy Szpital Sp. z o.o.
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Lublin, Polska, 20-601
- Zanamed Medical Clinic Sp. z o.o.
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Olsztyn, Polska, 10-117
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
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Olsztyn, Polska, 10-561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
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Oświęcim, Polska, 32-600
- Formed 2 Sp. z o.o.
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Warsaw, Polska, 02-507
- PANSTWOWY INSTYTUT MEDYCZNY MSWiA
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Zabrze, Polska, 41-800
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
-
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Silesian Voivodeship
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Chorzów, Silesian Voivodeship, Polska, 41-500
- M2M Med. Badania Sp. z o.o.
-
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California
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La Jolla, California, Stany Zjednoczone, 92037
- Scripps Whittier Diabetes Inst
-
Lancaster, California, Stany Zjednoczone, 93534
- First Valley Medical Group
-
Lincoln, California, Stany Zjednoczone, 95648
- Headlands Research CTR Lincoln
-
San Dimas, California, Stany Zjednoczone, 91773
- North America Research Institute
-
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Florida
-
Fleming Island, Florida, Stany Zjednoczone, 32003
- Northeast Research Institute
-
Hollywood, Florida, Stany Zjednoczone, 33024
- Encore Medical Research LLC
-
Miami, Florida, Stany Zjednoczone, 33155
- My Preferred Research
-
Mt. Dora, Florida, Stany Zjednoczone, 32757
- Adult Medicine of Lake County, Inc
-
Ocoee, Florida, Stany Zjednoczone, 34761
- West Orange Endocrinology
-
Orlando, Florida, Stany Zjednoczone, 32825
- Florida Inst For Clin Res LLC
-
Tamarac, Florida, Stany Zjednoczone, 33321
- Care Access
-
Weston, Florida, Stany Zjednoczone, 33331
- Encore Medical Research of Weston
-
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Nevada
-
Las Vegas, Nevada, Stany Zjednoczone, 89148
- Palm Research Center Inc-Vegas
-
-
New York
-
Brooklyn, New York, Stany Zjednoczone, 11220
- DM Clinical
-
-
North Carolina
-
Chapel Hill, North Carolina, Stany Zjednoczone, 27514
- University of North Carolina Chapel Hill
-
Morehead City, North Carolina, Stany Zjednoczone, 28557
- Carteret Medical Group
-
-
South Carolina
-
Spartanburg, South Carolina, Stany Zjednoczone, 29303
- Spartanburg Medical Research
-
-
Tennessee
-
Bristol, Tennessee, Stany Zjednoczone, 37620-7352
- Holston Medical Group Pc
-
Chattanooga, Tennessee, Stany Zjednoczone, 37404
- Southeast Renal Research Institute
-
Nashville, Tennessee, Stany Zjednoczone, 37203
- Clinical Research Associates
-
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Texas
-
Houston, Texas, Stany Zjednoczone, 77081
- Southwest Clinical Trials
-
Houston, Texas, Stany Zjednoczone, 77024
- Victorium Clinical Research
-
Houston, Texas, Stany Zjednoczone, 77054
- Prolato Clinical Research Cntr
-
Katy, Texas, Stany Zjednoczone, 77450
- Medical Colleagues-Texas LLP
-
San Antonio, Texas, Stany Zjednoczone, 78233
- Northeast Clinical Research of San Antonio
-
Shavano Park, Texas, Stany Zjednoczone, 78231
- Consano Clinical Research, LLC
-
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-
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Adana, Turcja (Türkiye), 01060
- Adana Şehir Eğitim ve Araştırma Hastanesi
-
Adapazarı/Turkiye, Turcja (Türkiye), 54100
- Sakarya Egitim ve Arastirma Hastanesi-Nefroloji
-
Afyonkarahisar, Turcja (Türkiye), 03200
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Nefroloji
-
Ankara, Turcja (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi
-
Ankara, Turcja (Türkiye), 06500
- Gazi Üniversitesi Hastanesi- Nefroloji
-
Gaziantep, Turcja (Türkiye), 27070
- Gaziantep Üniversitesi Hastanesi- Nefroloji
-
Izmir, Turcja (Türkiye), 35100
- Ege Üniversitesi Tip Fakultesi Hastanesi - Nefroloji
-
Kartal/İstanbul, Turcja (Türkiye), 34865
- Sağlık Bilimleri Üniversitesi Kartal Dr Lütfi Kırdar Şehir Hastanesi - Nefroloji
-
Kocaeli, Turcja (Türkiye), 41380
- Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
-
Yüreğir/ADANA, Turcja (Türkiye), 01250
- Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi
-
-
Melikgazi
-
Kayseri, Melikgazi, Turcja (Türkiye), 38039
- Erciyes Üniversitesi Hastanesi - Nefroloji
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Male or female (sex assigned at birth).
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes (T2D) above or equal to 180 days before screening.
- On stable once-daily dose of basal insulin (minimum of 0.25 Unit per kilogram per day or 20 Unit per day) at the investigator's discretion alone or in combination with metformin, sodium-glucose cotransporter 2 inhibitors (SGLT2i) or both (at stable effective or maximum tolerated dose as judged by the investigator) prior to screening. Basal insulin dose is considered stable when all doses during this period are within the range defined by plus minus 20%.
- History of chronic kidney disease based on medical records or as judged by the investigator.
- Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.
Exclusion Criteria:
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria before screening. However, insulin treatment for gestational diabetes or short-term insulin treatment for a maximum of 14 consecutive days is allowed.
- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.
- Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-vascular endothelial growth factor within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 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 nondilated examination.
- Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
- Chronic heart failure classified as being in New York Heart Association Class IV at screening.
- Planned coronary, carotid or peripheral artery revascularisation.
- Lupus nephritis or antineutrophil cytoplasmic (ANCA)-associated vasculitis.
- Any primary or secondary kidney disease requiring immunosuppressive therapy prior to screening.
- Chronic or intermittent haemodialysis or peritoneal dialysis before screening.
- Combination use of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin II receptor blocker (ARB) within 30 days prior to screening.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Komparator placebo: Placebo
Participants will receive placebo matched to zenagamtide subcutaneously. |
Placebo matched to zenagamtide will be administered subcutaneously once weekly. |
|
Eksperymentalny: Zenagamtide
Participants will receive zenagamtide subcutaneously. |
Zenagamtide will be administered subcutaneously once weekly. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in glycated haemoglobin (HbA1c)
Ramy czasowe: From baseline (week 0) to week 52
|
Measured in percentage (%)-points |
From baseline (week 0) to week 52
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Relative change in body weight
Ramy czasowe: From baseline (week 0) to week 52
|
Measured in percentage (%) |
From baseline (week 0) to week 52
|
|
Change in waist circumference
Ramy czasowe: From baseline (week 0) to week 52
|
Measured in centimeter (cm) |
From baseline (week 0) to week 52
|
|
Change in triglycerides
Ramy czasowe: From baseline (week 0) to week 52
|
Measured as ratio to baseline |
From baseline (week 0) to week 52
|
|
Change in Non-high-density lipoprotein (Non-HDL) cholesterol
Ramy czasowe: From baseline (week 0) to week 52
|
Measured as ratio to baseline |
From baseline (week 0) to week 52
|
|
Change in high-sensitivity C-reactive protein (hsCRP)
Ramy czasowe: From baseline (week 0) to week 52
|
Measured as ratio to baseline |
From baseline (week 0) to week 52
|
|
Change in systolic blood pressure
Ramy czasowe: From baseline (week 0) to week 52
|
Measured in millimeters of mercury (mmHg) |
From baseline (week 0) to week 52
|
|
Change in 7-point self-measured plasma glucose (SMPG) profiles: Mean postprandial increment (over all meals)
Ramy czasowe: From baseline (week 0) to week 52
|
Measured in millimole per litre (mmol/L) |
From baseline (week 0) to week 52
|
Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Dyrektor Studium: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby układu hormonalnego
- Procesy patologiczne
- Choroby układu moczowo-płciowego u mężczyzn
- Choroby nerek
- Choroby Urologiczne
- Choroby układu moczowo-płciowego kobiet
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Przewlekła choroba
- Atrybuty choroby
- Choroby metaboliczne
- Zaburzenia metabolizmu glukozy
- Cukrzyca
- Niewydolność nerek
- Stany patologiczne, oznaki i objawy
- Choroby żywieniowe i metaboliczne
- Cukrzyca typu 2
- Niewydolność nerek, przewlekła
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- NN9489-8034
- U1111-1335-3313 (Inny identyfikator: World Health Organization (WHO))
- 2026-525471-13 (Inny identyfikator: European Medical Agency (EMA))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .