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)
6 november 2026 uppdaterad av: Novo Nordisk A/S
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
450
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-post: clinicaltrials@novonordisk.com
Studieorter
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
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Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
- Hospital de Clínicas de Porto Alegre_Porto Alegre
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São Paulo
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Campinas, São Paulo, Brasilien, 13060-080
- Instituto de Pesquisa Clínica de Campinas
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São Paulo, São Paulo, Brasilien, 01228-000
- CPQuali Pesquisa Clínica Ltda
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-
-
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California
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La Jolla, California, Förenta staterna, 92037
- Scripps Whittier Diabetes Inst
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Lancaster, California, Förenta staterna, 93534
- First Valley Medical Group
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Lincoln, California, Förenta staterna, 95648
- Headlands Research CTR Lincoln
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San Dimas, California, Förenta staterna, 91773
- North America Research Institute
-
-
Florida
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Fleming Island, Florida, Förenta staterna, 32003
- Northeast Research Institute
-
Hollywood, Florida, Förenta staterna, 33024
- Encore Medical Research LLC
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Miami, Florida, Förenta staterna, 33155
- My Preferred Research
-
Mt. Dora, Florida, Förenta staterna, 32757
- Adult Medicine of Lake County, Inc
-
Ocoee, Florida, Förenta staterna, 34761
- West Orange Endocrinology
-
Orlando, Florida, Förenta staterna, 32825
- Florida Inst For Clin Res LLC
-
Tamarac, Florida, Förenta staterna, 33321
- Care Access
-
Weston, Florida, Förenta staterna, 33331
- Encore Medical Research of Weston
-
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Nevada
-
Las Vegas, Nevada, Förenta staterna, 89148
- Palm Research Center Inc-Vegas
-
-
New York
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Brooklyn, New York, Förenta staterna, 11220
- DM Clinical
-
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27514
- University of North Carolina Chapel Hill
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Morehead City, North Carolina, Förenta staterna, 28557
- Carteret Medical Group
-
-
South Carolina
-
Spartanburg, South Carolina, Förenta staterna, 29303
- Spartanburg Medical Research
-
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Tennessee
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Bristol, Tennessee, Förenta staterna, 37620-7352
- Holston Medical Group Pc
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Chattanooga, Tennessee, Förenta staterna, 37404
- Southeast Renal Research Institute
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Nashville, Tennessee, Förenta staterna, 37203
- Clinical Research Associates
-
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Texas
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Houston, Texas, Förenta staterna, 77081
- Southwest Clinical Trials
-
Houston, Texas, Förenta staterna, 77024
- Victorium Clinical Research
-
Houston, Texas, Förenta staterna, 77054
- Prolato Clinical Research Cntr
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Katy, Texas, Förenta staterna, 77450
- Medical Colleagues-Texas LLP
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San Antonio, Texas, Förenta staterna, 78233
- Northeast Clinical Research of San Antonio
-
Shavano Park, Texas, Förenta staterna, 78231
- Consano Clinical Research, LLC
-
-
-
-
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New Delhi, Indien, 110029
- All India Institute of Medical Sciences (AIIMS)
-
-
Andhra Pradesh
-
Guntur, Andhra Pradesh, Indien, 522001
- Endolife Specialty Hospitals
-
-
Chhattisgarh
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Raipur, Chhattisgarh, Indien, 492099
- All India Institute of Medical Sciences (AIIMS), Raipur
-
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Gujarat
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Vadodara, Gujarat, Indien, 390001
- SSG Hospital, Baroda
-
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Karnataka
-
Bangalore, Karnataka, Indien, 560092
- Life Care Hospital and Research Centre
-
-
Kerala
-
Kozhikode, Kerala, Indien, 673008
- Government Medical College, Kozhikode
-
-
Maharashtra
-
Kohlapur, Maharashtra, Indien, 416001
- Shree Mahalaxmi DIATONE Institute
-
Kolhāpur, Maharashtra, Indien, 416008
- Excel Endocrine Centre
-
Pune, Maharashtra, Indien, 411002
- Shree Samarth Hospital
-
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Punjab
-
Ludhiana, Punjab, Indien, 141001
- Dayanand Medical College & Hospital
-
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Rajasthan
-
Jaipur, Rajasthan, Indien, 302004
- SMS Medical College & Hospital
-
-
Tamil Nadu
-
Vellore, Tamil Nadu, Indien, 632004
- Christian Medical College Hospital, Vellore
-
-
Telangana
-
Hyderabad, Telangana, Indien, 500082
- NIZAM'S Institute of Medical Sciences
-
-
-
-
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Aichi, Japan, 468-0009
- TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
-
Arakawa-ku, Tokyo, Japan, 116-0012
- Kumanomae Nishimura Naika Clinic_Internal Medicine
-
Chiba-shi, Chiba, Japan, 260-0804
- Akaicho Clinic_Internal medicine
-
Chikushino-shi, Fukuoka, Japan, 818-0024
- Ito Naika Clinic_Internal Medicine and Diabetology
-
Gifu, Japan, 501-1194
- Gifu University Hospital_Diabetes and Endocrinology
-
Ibaraki, Japan, 311-0113
- Naka Kinen Clinic_Internal medicine
-
Kamakura-shi, Kanagawa, Japan, 247 0072
- Shonan Kamakura General Hospital_Diabetes and Endocrinology
-
Koriyama-shi, Fukushima, Japan, 963-8851
- Seino Internal Medicine Clinic_Internal medicine
-
Minato-ku, Tokyo, Japan, 105-8471
- The Jikei University Hospital_Diabetes, Metabolism, Endocrinology
-
Mito-shi, Ibaraki, Japan, 311-4153
- Minami Akatsuka Clinic_internal medicine
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Sendai, Miyagi, Japan, 981-8563
- Tohoku Rosai Hospital_Diabetes, Endocrinology and Hypertension
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Tamana-shi, Kumamoto, Japan, 865-0016
- Higashi Diabetes and Cardiovascular Clinic_Diabetes internal medicine, Cardiology
-
Tokyo, Japan, 103-0027
- Tokyo-Eki Center-building Clinic_Internal Medicine
-
Tokyo, Japan, 104-0031
- Fukuwa Clinic_Internal Medicine
-
Tsu-shi, Mie, Japan, 514-1101
- Mie Chuo Medical Center_Department of Diabetes and Endocrinology
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Wakayama, Japan, 640-8558
- Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology
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Japan
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Oita-shi, Oita,, Japan, Japan, 870 0039
- Abe Diabetes Clinic_Internal Medicine
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-
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Anhui
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Hefei, Anhui, Kina, 230012
- The Second People's Hospital of Hefei-Endocrinology
-
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Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina, 404199
- Chongqing University Three Gorges Hospital-Endocrinology
-
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Guangdong
-
Huizhou, Guangdong, Kina, 516001
- Huizhou Central People's Hospital-Endocrinology
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Shenzhen, Guangdong, Kina, 518035
- The Second People's Hospital of Shenzhen-Endocrinology
-
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Hebei
-
Hengshui, Hebei, Kina, 053000
- Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
-
Shijiazhuang, Hebei, Kina, 050000
- The Second Hospital of Hebei Medical University-Endocrinology
-
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Henan
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Kaifeng, Henan, Kina, 475000
- Huaihe Hospital of Henan University-Endocrinology
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Luoyang, Henan, Kina, 471003
- The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
-
Luoyang, Henan, Kina, 471002
- Luoyang First People's Hospital-Endocrinology
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Nanyang, Henan, Kina, 473058
- The First Affiliated Hospital of Nanyang Medical College-Endocrinology
-
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Hunan
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Changde, Hunan, Kina, 415003
- The First People's Hospital of Changde City-Endocrinology
-
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Jiangsu
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Changzhou, Jiangsu, Kina, 213004
- The First People's Hospital of Changzhou-Endocrinology
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Nanjing, Jiangsu, Kina, 210011
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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Zhenjiang, Jiangsu, Kina, 212001
- The Affiliated Hospital of Jiangsu University-Endocrinology
-
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Jilin
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Jilin City, Jilin, Kina, 130041
- The Second Norman Bethune Hospital of Jilin University-Endocrinology
-
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Shandong
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Jinan, Shandong, Kina, 250013
- Jinan Central Hospital-General Medicine
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 201200
- Shanghai Pudong New Area People's Hospital-Endocrinology
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Sichuan
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Chengdu, Sichuan, Kina, 610071
- Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Endocrinology
-
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Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300070
- Tianjin Medical University Chu Hsien-I Memorial Hospital-Endocrinology
-
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Zhejiang
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Huzhou, Zhejiang, Kina, 313000
- Huzhou Central Hospital-Endocrinology
-
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Gdansk, Polen, 80-214
- Uniwersyteckie Centrum Kliniczne
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Gmina Świecie, Polen, 86-100
- Nowy Szpital Sp. z o.o.
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Lublin, Polen, 20-601
- Zanamed Medical Clinic Sp. z o.o.
-
Olsztyn, Polen, 10-117
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
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Olsztyn, Polen, 10-561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
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Oświęcim, Polen, 32-600
- Formed 2 Sp. z o.o.
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Warsaw, Polen, 02-507
- PANSTWOWY INSTYTUT MEDYCZNY MSWiA
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Zabrze, Polen, 41-800
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
-
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Silesian Voivodeship
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Chorzów, Silesian Voivodeship, Polen, 41-500
- M2M Med. Badania Sp. z o.o.
-
-
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-
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Gwangju, Sydkorea, 61453
- Chosun University Hospital_Endocrinology
-
Seoul, Sydkorea, 01830
- Nowon Eulji Medical Center, Eulji University_Endocrinology
-
Seoul, Sydkorea, 03181
- Kangbuk Samsung Hospital_Endocrinology
-
Seoul, Sydkorea, 03080
- Seoul National University Hospital_Endocrinology
-
Seoul, Sydkorea, 03722
- Severance Hospital, Yonsei University Health System_Endocrinology
-
Seoul, Sydkorea, 06591
- The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology
-
Seoul, Sydkorea, 02841
- Korea University Anam Hospital_Endocrinology
-
Seoul, Sydkorea, 04763
- Hanyang University Seoul Hospital_Endocrinology
-
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Gangwon-do
-
Wŏnju, Gangwon-do, Sydkorea, 26426
- Wonju Severance Christian Hospital_Endocrinology
-
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Gyeonggi-do
-
Bucheon-si, Gyeonggi-do, Sydkorea, 14647
- The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
-
-
-
-
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Chrudim III, Tjeckien, 53701
- INTENDIA klinika s.r.o.
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Prague, Tjeckien, 150 00
- EUC Klinika Praha a.s.
-
Prague, Tjeckien, 10400
- ENDOTRIAL s.r.o.
-
Prague, Tjeckien, 140 00
- Medicon a.s.
-
Prague, Tjeckien, 149 00
- Milan Kvapil s.r.o.
-
Prague, Tjeckien, 160 00
- Fledip s.r.o.
-
Prague, Tjeckien, 190 00
- DiaIn s.r.o.
-
Praha Klanovice, Tjeckien, 190 14
- TreDia s.r.o.
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-
-
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Adana, Turkiet (Türkiye), 01060
- Adana Şehir Eğitim ve Araştırma Hastanesi
-
Adapazarı/Turkiye, Turkiet (Türkiye), 54100
- Sakarya Egitim ve Arastirma Hastanesi-Nefroloji
-
Afyonkarahisar, Turkiet (Türkiye), 03200
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Nefroloji
-
Ankara, Turkiet (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi
-
Ankara, Turkiet (Türkiye), 06500
- Gazi Üniversitesi Hastanesi- Nefroloji
-
Gaziantep, Turkiet (Türkiye), 27070
- Gaziantep Üniversitesi Hastanesi- Nefroloji
-
Izmir, Turkiet (Türkiye), 35100
- Ege Üniversitesi Tip Fakultesi Hastanesi - Nefroloji
-
Kartal/İstanbul, Turkiet (Türkiye), 34865
- Sağlık Bilimleri Üniversitesi Kartal Dr Lütfi Kırdar Şehir Hastanesi - Nefroloji
-
Kocaeli, Turkiet (Türkiye), 41380
- Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
-
Yüreğir/ADANA, Turkiet (Türkiye), 01250
- Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi
-
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Melikgazi
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Kayseri, Melikgazi, Turkiet (Türkiye), 38039
- Erciyes Üniversitesi Hastanesi - Nefroloji
-
-
-
-
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Bad Mergentheim, Tyskland, 97980
- Diabetespraxis Mergentheim
-
Berlin, Tyskland, 13597
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
-
Ludwigshafen, Tyskland, 67059
- Die Praxis am Ludwigsplatz
-
Mainz, Tyskland, 55116
- Gesundheitscentrum Mainz (Regner / Schmitt)
-
Münster, Tyskland, 48153
- MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
-
Pirna, Tyskland, 01796
- Hausärztliche und Diabetologische Praxis Pirna
-
Pohlheim, Tyskland, 35415
- ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo
Participants will receive placebo matched to zenagamtide subcutaneously. |
Placebo matched to zenagamtide will be administered subcutaneously once weekly. |
|
Experimentell: Zenagamtide
Participants will receive zenagamtide subcutaneously. |
Zenagamtide will be administered subcutaneously once weekly. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in glycated haemoglobin (HbA1c)
Tidsram: From baseline (week 0) to week 52
|
Measured in percentage (%)-points |
From baseline (week 0) to week 52
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Relative change in body weight
Tidsram: From baseline (week 0) to week 52
|
Measured in percentage (%) |
From baseline (week 0) to week 52
|
|
Change in waist circumference
Tidsram: From baseline (week 0) to week 52
|
Measured in centimeter (cm) |
From baseline (week 0) to week 52
|
|
Change in triglycerides
Tidsram: 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
Tidsram: 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)
Tidsram: From baseline (week 0) to week 52
|
Measured as ratio to baseline |
From baseline (week 0) to week 52
|
|
Change in systolic blood pressure
Tidsram: 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)
Tidsram: From baseline (week 0) to week 52
|
Measured in millimole per litre (mmol/L) |
From baseline (week 0) to week 52
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
10 november 2026
Primärt slutförande (Beräknad)
31 juli 2028
Avslutad studie (Beräknad)
25 september 2028
Studieregistreringsdatum
Först inskickad
6 november 2026
Först inskickad som uppfyllde QC-kriterierna
6 november 2026
Första postat (Faktisk)
12 november 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 november 2026
Senast verifierad
1 november 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Sjukdomar i det endokrina systemet
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Metaboliska sjukdomar
- Störningar i glukosmetabolism
- Diabetes mellitus
- Njurinsufficiens
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Diabetes mellitus, typ 2
- Njurinsufficiens, kronisk
Andra studie-ID-nummer
- NN9489-8034
- U1111-1335-3313 (Annan identifierare: World Health Organization (WHO))
- 2026-525471-13 (Annan identifierare: European Medical Agency (EMA))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .