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)
2026년 11월 6일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
450
단계
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Novo Nordisk
- 전화번호: (+1) 866-867-7178
- 이메일: clinicaltrials@novonordisk.com
연구 장소
-
-
-
Gwangju, 대한민국, 61453
- Chosun University Hospital_Endocrinology
-
Seoul, 대한민국, 01830
- Nowon Eulji Medical Center, Eulji University_Endocrinology
-
Seoul, 대한민국, 03181
- Kangbuk Samsung Hospital_Endocrinology
-
Seoul, 대한민국, 03080
- Seoul National University Hospital_Endocrinology
-
Seoul, 대한민국, 03722
- Severance Hospital, Yonsei University Health System_Endocrinology
-
Seoul, 대한민국, 06591
- The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology
-
Seoul, 대한민국, 02841
- Korea University Anam Hospital_Endocrinology
-
Seoul, 대한민국, 04763
- Hanyang University Seoul Hospital_Endocrinology
-
-
Gangwon-do
-
Wŏnju, Gangwon-do, 대한민국, 26426
- Wonju Severance Christian Hospital_Endocrinology
-
-
Gyeonggi-do
-
Bucheon-si, Gyeonggi-do, 대한민국, 14647
- The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
-
-
-
-
-
Bad Mergentheim, 독일, 97980
- Diabetespraxis Mergentheim
-
Berlin, 독일, 13597
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
-
Ludwigshafen, 독일, 67059
- Die Praxis am Ludwigsplatz
-
Mainz, 독일, 55116
- Gesundheitscentrum Mainz (Regner / Schmitt)
-
Münster, 독일, 48153
- MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
-
Pirna, 독일, 01796
- Hausärztliche und Diabetologische Praxis Pirna
-
Pohlheim, 독일, 35415
- ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
-
-
-
-
California
-
La Jolla, California, 미국, 92037
- Scripps Whittier Diabetes Inst
-
Lancaster, California, 미국, 93534
- First Valley Medical Group
-
Lincoln, California, 미국, 95648
- Headlands Research CTR Lincoln
-
San Dimas, California, 미국, 91773
- North America Research Institute
-
-
Florida
-
Fleming Island, Florida, 미국, 32003
- Northeast Research Institute
-
Hollywood, Florida, 미국, 33024
- Encore Medical Research LLC
-
Miami, Florida, 미국, 33155
- My Preferred Research
-
Mt. Dora, Florida, 미국, 32757
- Adult Medicine of Lake County, Inc
-
Ocoee, Florida, 미국, 34761
- West Orange Endocrinology
-
Orlando, Florida, 미국, 32825
- Florida Inst For Clin Res LLC
-
Tamarac, Florida, 미국, 33321
- Care Access
-
Weston, Florida, 미국, 33331
- Encore Medical Research of Weston
-
-
Nevada
-
Las Vegas, Nevada, 미국, 89148
- Palm Research Center Inc-Vegas
-
-
New York
-
Brooklyn, New York, 미국, 11220
- DM Clinical
-
-
North Carolina
-
Chapel Hill, North Carolina, 미국, 27514
- University of North Carolina Chapel Hill
-
Morehead City, North Carolina, 미국, 28557
- Carteret Medical Group
-
-
South Carolina
-
Spartanburg, South Carolina, 미국, 29303
- Spartanburg Medical Research
-
-
Tennessee
-
Bristol, Tennessee, 미국, 37620-7352
- Holston Medical Group Pc
-
Chattanooga, Tennessee, 미국, 37404
- Southeast Renal Research Institute
-
Nashville, Tennessee, 미국, 37203
- Clinical Research Associates
-
-
Texas
-
Houston, Texas, 미국, 77081
- Southwest Clinical Trials
-
Houston, Texas, 미국, 77024
- Victorium Clinical Research
-
Houston, Texas, 미국, 77054
- Prolato Clinical Research Cntr
-
Katy, Texas, 미국, 77450
- Medical Colleagues-Texas LLP
-
San Antonio, Texas, 미국, 78233
- Northeast Clinical Research of San Antonio
-
Shavano Park, Texas, 미국, 78231
- Consano Clinical Research, LLC
-
-
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, 브라질, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
-
Porto Alegre, Rio Grande do Sul, 브라질, 90035-903
- Hospital de Clínicas de Porto Alegre_Porto Alegre
-
-
São Paulo
-
Campinas, São Paulo, 브라질, 13060-080
- Instituto de Pesquisa Clínica de Campinas
-
São Paulo, São Paulo, 브라질, 01228-000
- CPQuali Pesquisa Clínica Ltda
-
-
-
-
-
New Delhi, 인도, 110029
- All India Institute of Medical Sciences (AIIMS)
-
-
Andhra Pradesh
-
Guntur, Andhra Pradesh, 인도, 522001
- Endolife Specialty Hospitals
-
-
Chhattisgarh
-
Raipur, Chhattisgarh, 인도, 492099
- All India Institute of Medical Sciences (AIIMS), Raipur
-
-
Gujarat
-
Vadodara, Gujarat, 인도, 390001
- SSG Hospital, Baroda
-
-
Karnataka
-
Bangalore, Karnataka, 인도, 560092
- Life Care Hospital and Research Centre
-
-
Kerala
-
Kozhikode, Kerala, 인도, 673008
- Government Medical College, Kozhikode
-
-
Maharashtra
-
Kohlapur, Maharashtra, 인도, 416001
- Shree Mahalaxmi DIATONE Institute
-
Kolhāpur, Maharashtra, 인도, 416008
- Excel Endocrine Centre
-
Pune, Maharashtra, 인도, 411002
- Shree Samarth Hospital
-
-
Punjab
-
Ludhiana, Punjab, 인도, 141001
- Dayanand Medical College & Hospital
-
-
Rajasthan
-
Jaipur, Rajasthan, 인도, 302004
- SMS Medical College & Hospital
-
-
Tamil Nadu
-
Vellore, Tamil Nadu, 인도, 632004
- Christian Medical College Hospital, Vellore
-
-
Telangana
-
Hyderabad, Telangana, 인도, 500082
- NIZAM'S Institute of Medical Sciences
-
-
-
-
-
Aichi, 일본, 468-0009
- TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
-
Arakawa-ku, Tokyo, 일본, 116-0012
- Kumanomae Nishimura Naika Clinic_Internal Medicine
-
Chiba-shi, Chiba, 일본, 260-0804
- Akaicho Clinic_Internal medicine
-
Chikushino-shi, Fukuoka, 일본, 818-0024
- Ito Naika Clinic_Internal Medicine and Diabetology
-
Gifu, 일본, 501-1194
- Gifu University Hospital_Diabetes and Endocrinology
-
Ibaraki, 일본, 311-0113
- Naka Kinen Clinic_Internal medicine
-
Kamakura-shi, Kanagawa, 일본, 247 0072
- Shonan Kamakura General Hospital_Diabetes and Endocrinology
-
Koriyama-shi, Fukushima, 일본, 963-8851
- Seino Internal Medicine Clinic_Internal medicine
-
Minato-ku, Tokyo, 일본, 105-8471
- The Jikei University Hospital_Diabetes, Metabolism, Endocrinology
-
Mito-shi, Ibaraki, 일본, 311-4153
- Minami Akatsuka Clinic_internal medicine
-
Sendai, Miyagi, 일본, 981-8563
- Tohoku Rosai Hospital_Diabetes, Endocrinology and Hypertension
-
Tamana-shi, Kumamoto, 일본, 865-0016
- Higashi Diabetes and Cardiovascular Clinic_Diabetes internal medicine, Cardiology
-
Tokyo, 일본, 103-0027
- Tokyo-Eki Center-building Clinic_Internal Medicine
-
Tokyo, 일본, 104-0031
- Fukuwa Clinic_Internal Medicine
-
Tsu-shi, Mie, 일본, 514-1101
- Mie Chuo Medical Center_Department of Diabetes and Endocrinology
-
Wakayama, 일본, 640-8558
- Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology
-
-
Japan
-
Oita-shi, Oita,, Japan, 일본, 870 0039
- Abe Diabetes Clinic_Internal Medicine
-
-
-
-
Anhui
-
Hefei, Anhui, 중국, 230012
- The Second People's Hospital of Hefei-Endocrinology
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, 중국, 404199
- Chongqing University Three Gorges Hospital-Endocrinology
-
-
Guangdong
-
Huizhou, Guangdong, 중국, 516001
- Huizhou Central People's Hospital-Endocrinology
-
Shenzhen, Guangdong, 중국, 518035
- The Second People's Hospital of Shenzhen-Endocrinology
-
-
Hebei
-
Hengshui, Hebei, 중국, 053000
- Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
-
Shijiazhuang, Hebei, 중국, 050000
- The Second Hospital of Hebei Medical University-Endocrinology
-
-
Henan
-
Kaifeng, Henan, 중국, 475000
- Huaihe Hospital of Henan University-Endocrinology
-
Luoyang, Henan, 중국, 471003
- The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
-
Luoyang, Henan, 중국, 471002
- Luoyang First People's Hospital-Endocrinology
-
Nanyang, Henan, 중국, 473058
- The First Affiliated Hospital of Nanyang Medical College-Endocrinology
-
-
Hunan
-
Changde, Hunan, 중국, 415003
- The First People's Hospital of Changde City-Endocrinology
-
-
Jiangsu
-
Changzhou, Jiangsu, 중국, 213004
- The First People's Hospital of Changzhou-Endocrinology
-
Nanjing, Jiangsu, 중국, 210011
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
-
Zhenjiang, Jiangsu, 중국, 212001
- The Affiliated Hospital of Jiangsu University-Endocrinology
-
-
Jilin
-
Jilin City, Jilin, 중국, 130041
- The Second Norman Bethune Hospital of Jilin University-Endocrinology
-
-
Shandong
-
Jinan, Shandong, 중국, 250013
- Jinan Central Hospital-General Medicine
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, 중국, 201200
- Shanghai Pudong New Area People's Hospital-Endocrinology
-
-
Sichuan
-
Chengdu, Sichuan, 중국, 610071
- Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Endocrinology
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, 중국, 300070
- Tianjin Medical University Chu Hsien-I Memorial Hospital-Endocrinology
-
-
Zhejiang
-
Huzhou, Zhejiang, 중국, 313000
- Huzhou Central Hospital-Endocrinology
-
-
-
-
-
Chrudim III, 체코, 53701
- INTENDIA klinika s.r.o.
-
Prague, 체코, 150 00
- EUC Klinika Praha a.s.
-
Prague, 체코, 10400
- ENDOTRIAL s.r.o.
-
Prague, 체코, 140 00
- Medicon a.s.
-
Prague, 체코, 149 00
- Milan Kvapil s.r.o.
-
Prague, 체코, 160 00
- Fledip s.r.o.
-
Prague, 체코, 190 00
- DiaIn s.r.o.
-
Praha Klanovice, 체코, 190 14
- TreDia s.r.o.
-
-
-
-
-
Adana, 터키 (Türkiye), 01060
- Adana Şehir Eğitim ve Araştırma Hastanesi
-
Adapazarı/Turkiye, 터키 (Türkiye), 54100
- Sakarya Egitim ve Arastirma Hastanesi-Nefroloji
-
Afyonkarahisar, 터키 (Türkiye), 03200
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Nefroloji
-
Ankara, 터키 (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi
-
Ankara, 터키 (Türkiye), 06500
- Gazi Üniversitesi Hastanesi- Nefroloji
-
Gaziantep, 터키 (Türkiye), 27070
- Gaziantep Üniversitesi Hastanesi- Nefroloji
-
Izmir, 터키 (Türkiye), 35100
- Ege Üniversitesi Tip Fakultesi Hastanesi - Nefroloji
-
Kartal/İstanbul, 터키 (Türkiye), 34865
- Sağlık Bilimleri Üniversitesi Kartal Dr Lütfi Kırdar Şehir Hastanesi - Nefroloji
-
Kocaeli, 터키 (Türkiye), 41380
- Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
-
Yüreğir/ADANA, 터키 (Türkiye), 01250
- Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi
-
-
Melikgazi
-
Kayseri, Melikgazi, 터키 (Türkiye), 38039
- Erciyes Üniversitesi Hastanesi - Nefroloji
-
-
-
-
-
Gdansk, 폴란드, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Gmina Świecie, 폴란드, 86-100
- Nowy Szpital Sp. z o.o.
-
Lublin, 폴란드, 20-601
- Zanamed Medical Clinic Sp. z o.o.
-
Olsztyn, 폴란드, 10-117
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
-
Olsztyn, 폴란드, 10-561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
-
Oświęcim, 폴란드, 32-600
- Formed 2 Sp. z o.o.
-
Warsaw, 폴란드, 02-507
- PANSTWOWY INSTYTUT MEDYCZNY MSWiA
-
Zabrze, 폴란드, 41-800
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
-
-
Silesian Voivodeship
-
Chorzów, Silesian Voivodeship, 폴란드, 41-500
- M2M Med. Badania Sp. z o.o.
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
위약 비교기: Placebo
Participants will receive placebo matched to zenagamtide subcutaneously. |
Placebo matched to zenagamtide will be administered subcutaneously once weekly. |
|
실험적: Zenagamtide
Participants will receive zenagamtide subcutaneously. |
Zenagamtide will be administered subcutaneously once weekly. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in glycated haemoglobin (HbA1c)
기간: From baseline (week 0) to week 52
|
Measured in percentage (%)-points |
From baseline (week 0) to week 52
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Relative change in body weight
기간: From baseline (week 0) to week 52
|
Measured in percentage (%) |
From baseline (week 0) to week 52
|
|
Change in waist circumference
기간: From baseline (week 0) to week 52
|
Measured in centimeter (cm) |
From baseline (week 0) to week 52
|
|
Change in triglycerides
기간: 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
기간: 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)
기간: From baseline (week 0) to week 52
|
Measured as ratio to baseline |
From baseline (week 0) to week 52
|
|
Change in systolic blood pressure
기간: 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)
기간: From baseline (week 0) to week 52
|
Measured in millimole per litre (mmol/L) |
From baseline (week 0) to week 52
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 연구 책임자: Clinical Transparency (dept. 2834), Novo Nordisk A/S
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 11월 10일
기본 완료 (추정된)
기본 완료
2028년 7월 31일
연구 완료 (추정된)
연구 완료
2028년 9월 25일
연구 등록 날짜
최초 제출
최초 제출
2026년 11월 6일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 11월 6일
처음 게시됨 (실제)
처음 게시됨
2026년 11월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 11월 12일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 11월 6일
마지막으로 확인됨
마지막으로 확인됨
2026년 11월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- NN9489-8034
- U1111-1335-3313 (기타 식별자: World Health Organization (WHO))
- 2026-525471-13 (기타 식별자: European Medical Agency (EMA))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .