NCT07797335

Brief Summary

This study is being conducted to find out how well zenagamtide works and how safe it is compared to insulin glargine in participants with type 2 diabetes who are at higher risk of heart and blood vessel problems and are already taking 1 to 3 diabetes medications. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide, (the treatment being tested) or insulin glargine (a comparator) and which treatment participants get is decided by chance.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,778

participants targeted

Target at P75+ for phase_3 type-2-diabetes

Timeline
24mo left

Started Aug 2026

Typical duration for phase_3 type-2-diabetes

Geographic Reach
16 countries

330 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Aug 2026Sep 2028

Study Start

First participant enrolled

August 24, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2028

Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

1.9 years

First QC Date

August 26, 2026

Last Update Submit

August 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c)

    Measured as percentage (%)-points

    From baseline (week 0) to week 52

Secondary Outcomes (9)

  • Time to first occurrence of a 4-point major adverse cardiovascular events (MACE) endpoint consisting of: Cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina

    From baseline (week 0) to 104 weeks or more

  • Relative change in body weight

    From baseline (week 0) to week 52

  • Superiority of zenagamtide versus insulin: Change in HbA1c

    From baseline (week 0) to week 52

  • Time to first occurrence of a 3-point MACE endpoint consisting of: CV death, non-fatal myocardial infarction and non-fatal stroke

    From baseline (week 0) to 104 weeks or more

  • Change in waist circumference

    From baseline (week 0) to week 52

  • +4 more secondary outcomes

Study Arms (2)

Zenagamtide

EXPERIMENTAL

Participants will receive zenagamtide subcutaneously once weekly to one of the body parts: thigh, abdomen or upper arm.

Drug: Zenagamtide

Insulin glargine U-100

ACTIVE COMPARATOR

Participants will receive Insulin glargine U-100 subcutaneously once daily to one of the body parts: thigh, abdomen or upper arm.

Drug: Insulin glargine U-100

Interventions

Insulin glargine U-100 will be administered subcutaneously using SoloSTAR pen-injector to one of the body parts: thigh, abdomen or upper arm (rotation of the injection site within body parts).

Insulin glargine U-100

Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm (administration to the same body part throughout the study).

Zenagamtide

Eligibility Criteria

Age45 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Male or female (sex assigned at birth, inclusive of all gender identities).
  • Age 45 years or above at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 180 days before screening.
  • Treatment with 1-3 marketed oral glucose-lowering medications (metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors (SGLT2i), α-glucosidase inhibitors (AGI), or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral glucose-lowering medications must be stable (same drug(s), stable daily dose(s)) before screening.
  • Have HbA1c as determined by central laboratory at screening, if background glucose-lowering medications does not include a SU, or if background glucose-lowering medications includes a SU.
  • Increased risk of cardiovascular events as evidenced by at least one of the following (a-e):
  • Prior myocardial infarction (MI)
  • Documented coronary artery disease defined by at least one of the following:
  • ≥ 50% stenosis of coronary artery on angiography or other imaging modality.
  • Ischaemia documented by stress test with any imaging modality.
  • Prior unstable angina with electrocardiogram (ECG) changes.
  • Prior coronary artery bypass graft or prior percutaneous coronary intervention.
  • Prior stroke (ischemic or haemorrhagic stroke).
  • History of chronic kidney disease based on medical records or as judged by the investigator as determined by central laboratory at screening.
  • +5 more criteria

You may not qualify if:

  • Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
  • Planned coronary, carotid or peripheral artery revascularisation.
  • Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
  • Diabetes- or weight related:
  • Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), dipeptidyl peptidase 4 (DPP-4) inhibitors or amylin analogues before screening.
  • Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) 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 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 non-dilated examination.
  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.
  • Any episodes of diabetic ketoacidosis before screening.
  • Uncontrolled thyroid disease as per investigator's discretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (330)

Univ of Alabama Birmingham

Birmingham, Alabama, 35294, United States

NOT YET RECRUITING

Eastern Shore Rsrch Inst, LLC

Fairhope, Alabama, 36532, United States

RECRUITING

Chambliss Clinical Trials, LLC

Montgomery, Alabama, 36106, United States

RECRUITING

Honor Health

Scottsdale, Arizona, 85258, United States

NOT YET RECRUITING

First Valley Medical Group

Lancaster, California, 93534, United States

RECRUITING

Headlands Research CTR Lincoln

Lincoln, California, 95648, United States

RECRUITING

Torrance Clin Res Inst, Inc.

Lomita, California, 90717, United States

RECRUITING

Pacific Clinical Studies

Los Alamitos, California, 90720, United States

RECRUITING

VAGLAHS Clinical Research Center (CRC)

Los Angeles, California, 90073, United States

NOT YET RECRUITING

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

RECRUITING

Paradigm Clinical Research

San Diego, California, 92108, United States

RECRUITING

N America Res Inst - San Dimas

San Dimas, California, 91773, United States

RECRUITING

Encompass Clinical Research_Spring Valley

Spring Valley, California, 91978, United States

RECRUITING

Innovative Research of W FL

Clearwater, Florida, 33756, United States

RECRUITING

Nature Coast Clin Rsrch_Crystal River

Crystal River, Florida, 34429, United States

NOT YET RECRUITING

Florida Premier Cardiology

Delray Beach, Florida, 33484, United States

NOT YET RECRUITING

Encore Medical Research LLC

Hollywood, Florida, 33024, United States

RECRUITING

East Coast Institute For Research

Jacksonville, Florida, 32216, United States

NOT YET RECRUITING

Jacksonville Ctr for Clin Res

Jacksonville, Florida, 32216, United States

NOT YET RECRUITING

Clinical Research of Cent FL

Lakeland, Florida, 33805, United States

RECRUITING

Life Spring Research Foundation LLC

Miami, Florida, 33130, United States

RECRUITING

Optimus U, Corp

Miami, Florida, 33135, United States

NOT YET RECRUITING

Flourish Research - North Miami

Miami, Florida, 33138, United States

NOT YET RECRUITING

Inpatient Research Clinic LLC

Miami Lakes, Florida, 33014, United States

NOT YET RECRUITING

San Marcus Res Clin Miami Lakes

Miami Lakes, Florida, 33014, United States

RECRUITING

Trujillo Medical Centers

Miramar, Florida, 33027, United States

RECRUITING

Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States

NOT YET RECRUITING

Ocala Cardiovascular Research

Ocala, Florida, 34471, United States

RECRUITING

Suncoast Clinical Research, Inc.

Palm Harbor, Florida, 34684, United States

NOT YET RECRUITING

Suncoast Research Associates LLC

Pembroke Pines, Florida, 33024, United States

NOT YET RECRUITING

St Johns Center for Clin. Res

Saint Augustine, Florida, 32086, United States

RECRUITING

Javara/Privia Med Grp GA,LLC

Albany, Georgia, 31707, United States

RECRUITING

David Kavtaradze MD, Inc.

Cordele, Georgia, 31015, United States

NOT YET RECRUITING

Atlanta Heart Specialist

Tucker, Georgia, 30084, United States

NOT YET RECRUITING

Rocky Mountain Diab&Osteo Ctr

Idaho Falls, Idaho, 83404, United States

RECRUITING

Elevate Clinical Research

Gurnee, Illinois, 60031, United States

RECRUITING

Chicago Medical Research LLC

Hazel Crest, Illinois, 60429, United States

RECRUITING

Genesis Orthopedics & Sports Medicine

Oak Brook, Illinois, 60523, United States

NOT YET RECRUITING

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

NOT YET RECRUITING

American Health Network of IN LLC_Franklin

Franklin, Indiana, 46131, United States

NOT YET RECRUITING

American Health Network of Indiana, LLC_Greenfield

Greenfield, Indiana, 46140, United States

NOT YET RECRUITING

American Health Network of IN LLC

Muncie, Indiana, 47304, United States

NOT YET RECRUITING

West Broadway Clinic

Council Bluffs, Iowa, 51501, United States

RECRUITING

University of Iowa Prev Inter Ctr

Iowa City, Iowa, 52772, United States

NOT YET RECRUITING

Iowa Diab & Endo Res Center

West Des Moines, Iowa, 50266, United States

NOT YET RECRUITING

Cotton O'Neil Diab & Endo Ctr

Topeka, Kansas, 66606, United States

RECRUITING

The Research Group of Lexington LLC

Lexington, Kentucky, 40503, United States

RECRUITING

Louisiana Heart Center

Covington, Louisiana, 70433, United States

NOT YET RECRUITING

Ascension Saint Agnes Heart Ca

Baltimore, Maryland, 21229, United States

NOT YET RECRUITING

MedStar Good Samaritan Hosp

Baltimore, Maryland, 21239, United States

NOT YET RECRUITING

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

NOT YET RECRUITING

Elite Research Center

Flint, Michigan, 48532, United States

RECRUITING

Arcturus Healthcare, PLC.

Troy, Michigan, 48098, United States

RECRUITING

Trinity Health Michigan Heart

Ypsilanti, Michigan, 48197, United States

NOT YET RECRUITING

Johnson County ClinTrials

Kansas City, Missouri, 64112, United States

NOT YET RECRUITING

Amicis Centers of Clinical Research

St Louis, Missouri, 63128, United States

RECRUITING

Methodist Phys. Clinic

Omaha, Nebraska, 68114, United States

RECRUITING

Palm Research Center Inc-Vegas

Las Vegas, Nevada, 89128, United States

NOT YET RECRUITING

Central New York Clinical Research CNYCR

Manlius, New York, 13104, United States

NOT YET RECRUITING

Mid Hudson Med Res-New Windsor

New Windsor, New York, 12553, United States

RECRUITING

Harlem Cardiology_Madison ave

New York, New York, 10035, United States

NOT YET RECRUITING

NYC Health + Hospitals/Lincoln

The Bronx, New York, 10451, United States

NOT YET RECRUITING

Prime Global Research Inc.

The Bronx, New York, 10456, United States

RECRUITING

Southgate Medical Group, LLP

West Seneca, New York, 14224, United States

NOT YET RECRUITING

Carteret Medical Group

Morehead City, North Carolina, 28557, United States

RECRUITING

Piedmont Healthcare/Research

Statesville, North Carolina, 28625, United States

RECRUITING

Accellacare

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Univ of Cincinnati Med Cent

Cincinnati, Ohio, 45267, United States

NOT YET RECRUITING

Advanced Med Res Maumee

Maumee, Ohio, 43537, United States

RECRUITING

Lynn Institute of Norman

Norman, Oklahoma, 73072, United States

RECRUITING

Heritage Valley Medical Group

Beaver, Pennsylvania, 15009, United States

NOT YET RECRUITING

Capital Area Research LLC

Newport, Pennsylvania, 17074, United States

RECRUITING

Piedmont Research Partners, LLC

Fort Mill, South Carolina, 29707, United States

RECRUITING

Accellacare US Inc._SC

Mt. Pleasant, South Carolina, 29464, United States

NOT YET RECRUITING

Trial Management Associates

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Holston Medical Group Pc

Bristol, Tennessee, 37620-7352, United States

RECRUITING

The Alliance for Multispecialty Research LLC AMR

Knoxville, Tennessee, 37909, United States

NOT YET RECRUITING

MidState Endocrine Associates

Nashville, Tennessee, 37203, United States

RECRUITING

PharmaTex Research

Amarillo, Texas, 79106, United States

NOT YET RECRUITING

Pinnacle Clinical Research

Austin, Texas, 78757, United States

NOT YET RECRUITING

Javara Inc. / Privia Medical Group Gulf Coast PLLC

Conroe, Texas, 77384, United States

RECRUITING

Osvaldo A. Brusco MD

Corpus Christi, Texas, 78414, United States

NOT YET RECRUITING

Thyroid Endocrinology & Diabetes PA

Dallas, Texas, 75208, United States

RECRUITING

Baylor Jack and Jane Hamilton

Dallas, Texas, 75226, United States

NOT YET RECRUITING

Diabetes and Thyroid Ctr of FW

Fort Worth, Texas, 76132, United States

NOT YET RECRUITING

PrimeCare Medical Group

Houston, Texas, 77024, United States

RECRUITING

JCCT- Juno NW Houston

Houston, Texas, 77040, United States

RECRUITING

Biopharma Informatic_Houston

Houston, Texas, 77043, United States

RECRUITING

Northwest Houston Cardiology, P.A.

Houston, Texas, 77070, United States

RECRUITING

Endocrine And Psychiatry Center

Houston, Texas, 77095, United States

NOT YET RECRUITING

Prem Internal Med Asso Houston

Katy, Texas, 77493, United States

RECRUITING

DCOL Ctr for Clin Res

Longview, Texas, 75605, United States

RECRUITING

Texas Inst, Kdny & Endo Disor

Lufkin, Texas, 75904, United States

RECRUITING

PRX Research

Mesquite, Texas, 75149, United States

NOT YET RECRUITING

Clinical Advancement Center

San Antonio, Texas, 78212, United States

RECRUITING

The IMA Group IMA Clinical Trials of America Inc. CTA

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

Univ Of Texas Hlth Science Cntr

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

VIP Trials

San Antonio, Texas, 78230, United States

RECRUITING

NE Clin Res of San Antonio

San Antonio, Texas, 78233, United States

RECRUITING

Simcare Medical Research, LLC

Sugar Land, Texas, 77478, United States

RECRUITING

Valley Diab. & Endo Comp Ctr

Weslaco, Texas, 78596, United States

NOT YET RECRUITING

Progressive Clinical Research UT

Bountiful, Utah, 84010, United States

NOT YET RECRUITING

Alpine Research Association

Layton, Utah, 84041, United States

RECRUITING

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

NOT YET RECRUITING

Carient Heart and Vascular

Manassas, Virginia, 20109, United States

NOT YET RECRUITING

Dominion Medical Associates

Richmond, Virginia, 23219, United States

NOT YET RECRUITING

VA Medical Center_Salem

Salem, Virginia, 24153, United States

NOT YET RECRUITING

Selma Medical Associates

Winchester, Virginia, 22601-3834, United States

RECRUITING

Instituto de Investigaciones Clínicas Bahia Blanca

Bahía Blanca, Buenos Aires, B8000, Argentina

NOT YET RECRUITING

CEMEDIC

CABA, Buenos Aires, C1440CFD, Argentina

NOT YET RECRUITING

Dolz Investigacion Clinica

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1048, Argentina

NOT YET RECRUITING

Fundación Respirar

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426, Argentina

NOT YET RECRUITING

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Buenos Aires, B7600GNY, Argentina

NOT YET RECRUITING

CIMRO

San Rafael, Mendoza Province, M5602GGS, Argentina

NOT YET RECRUITING

Centro Oncológico de Excelencia (COE)

San Juan, San Juan Province, J5400, Argentina

NOT YET RECRUITING

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, S2000DEJ, Argentina

NOT YET RECRUITING

Nuvexa

Rosario, Santa Fe Province, S2000, Argentina

NOT YET RECRUITING

OMI- Organización Médica de Investigación

Buenos Aires, C1015, Argentina

NOT YET RECRUITING

Hospital Sirio Libanes

Buenos Aires, C1419, Argentina

NOT YET RECRUITING

Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

Buenos Aires, C1425AGC, Argentina

NOT YET RECRUITING

CIPREC Arenales

CABA, C1061AAS, Argentina

NOT YET RECRUITING

Centro Médico Viamonte SRL

CABA, C1120AAC, Argentina

NOT YET RECRUITING

CENUDIAB Centro Médico de Nutrición v Diabetes

CABA, C1440AAD, Argentina

NOT YET RECRUITING

Centro Diabetologico Cordoba Dr. Waitman

Córdoba, 5000, Argentina

NOT YET RECRUITING

Centro médico privado Cemaic

Córdoba, X5008, Argentina

NOT YET RECRUITING

CIPADI

Godoy Cruz, M5501ARP, Argentina

NOT YET RECRUITING

Clínica Mayo de Urgencias Médicas Cruz Blanca

San Miguel de Tucumán, T4000IHE, Argentina

NOT YET RECRUITING

CPHosp Manaus Medicina, Ensino e Pesquisa LTDA

Manaus, Amazonas, 69057-088, Brazil

NOT YET RECRUITING

Instituto de Ensino e Pesquisa Clínica do Ceará Ltda

Fortaleza, Ceará, 60135-270, Brazil

NOT YET RECRUITING

CECAP - Centro de Cardiologia Clínica e Pesquisa Dra. Juliana Souza

Brasília, Federal District, 70673-416, Brazil

NOT YET RECRUITING

Instituto de Ciências Farmacêuticas de Estudos e Pesquisas

Aparecida de Goiânia, Goiás, 74935-530, Brazil

NOT YET RECRUITING

Hospital das Clínicas da Universidade Federal de Goiás

Goiânia, Goiás, 74605-020, Brazil

NOT YET RECRUITING

Eurolatino Medical Research Center

Uberlândia, Minas Gerais, 38400-500, Brazil

NOT YET RECRUITING

Centro de Diabetes Curitiba

Curitiba, Paraná, 80810-040, Brazil

NOT YET RECRUITING

Hospital Universitário João de Barros Barreto - UFPA

Belém, Pará, 66073-000, Brazil

NOT YET RECRUITING

Lóbus Centro de Pesquisa Clínica LTDA

Volta Redonda, Rio de Janeiro, 27258-000, Brazil

NOT YET RECRUITING

Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista

Bragança Paulista, São Paulo, 12916-542, Brazil

NOT YET RECRUITING

Instituto de Pesquisa Clínica de Campinas

Campinas, São Paulo, 13060-080, Brazil

NOT YET RECRUITING

i9 Pesquisas Clínicas

Campinas, São Paulo, 13092-133, Brazil

NOT YET RECRUITING

Instituto de Pesquisa Clinica (IPEC)

São Paulo, São Paulo, 01223-001, Brazil

NOT YET RECRUITING

CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, 01228-000, Brazil

NOT YET RECRUITING

Instituto do Coração - HCFMUSP

São Paulo, São Paulo, 05403-000, Brazil

NOT YET RECRUITING

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

Sao Jose Rio Preto, 15090-000, Brazil

NOT YET RECRUITING

CEPIC - Centro Paulista de Investigacao Clinica

São Paulo, 04266-010, Brazil

NOT YET RECRUITING

Medical centre Asclepius OOD

Dupnitsa, Kyustendil, 2600, Bulgaria

NOT YET RECRUITING

Medical Center Diya Med EOOD

Burgas, 8000, Bulgaria

NOT YET RECRUITING

MC Diamedical - 2013 OOD, Dimitrovgrad

Dimitrovgrad, 6400, Bulgaria

NOT YET RECRUITING

Medical Center Viva Feniks OOD

Dobrich, 9300, Bulgaria

NOT YET RECRUITING

AIPSOMCEMD Dr. Velichka Zlatareva EOOD

Plovdiv, 4030, Bulgaria

NOT YET RECRUITING

Medical center Smolyan clinical research OOD

Smolyan, 4700, Bulgaria

NOT YET RECRUITING

Medical centre Vitclinic EOOD

Sofia, 1680, Bulgaria

NOT YET RECRUITING

Prevencia - 2000 - MCOC OOD

Stara Zagora, 6000, Bulgaria

NOT YET RECRUITING

MC Berbatov EOOD, Beli Drin

Yambol, 8600, Bulgaria

NOT YET RECRUITING

Centricity Research Calgary Endocrinology

Calgary, Alberta, T2H 2G4, Canada

NOT YET RECRUITING

University of Alberta_Edmonton

Edmonton, Alberta, T6G 2B7, Canada

NOT YET RECRUITING

CARe Clinic Ltd.

Red Deer, Alberta, T4P 1K4, Canada

NOT YET RECRUITING

Medical Arts Health Research Group_Kelowna_0

Kelowna, British Columbia, V1Y 4N7, Canada

NOT YET RECRUITING

Kelowna Health and Memory Centre Ltd.

Kelowna, British Columbia, V1Y 5A8, Canada

NOT YET RECRUITING

Care Access Cape Breton

Sydney, Nova Scotia, B1M 0A1, Canada

NOT YET RECRUITING

Bluewater Clin Res Group Inc

Sarnia, Ontario, N7T 4X3, Canada

NOT YET RECRUITING

Stouffville Medical Research Institute

Stouffville, Ontario, L4A 1H2, Canada

NOT YET RECRUITING

Centricity Research Toronto

Toronto, Ontario, M4G 3E8, Canada

NOT YET RECRUITING

Centre de Médecine Métabolique de Lanaudière

Terrebonne, Quebec, J6X 4P7, Canada

NOT YET RECRUITING

The Second People's Hospital of Hefei-Endocrinology

Hefei, Anhui, 230012, China

NOT YET RECRUITING

The Second Hospital of Anhui Medical University-Endocrinology

Hefei, Anhui, 230061, China

NOT YET RECRUITING

Chinese Academy of Medical Sciences Fuwai Hospital-Endocrinology

Beijing, Beijing Municipality, 100037, China

NOT YET RECRUITING

Peking University People's Hospital-Endocrinology

Beijing, Beijing Municipality, 100044, China

NOT YET RECRUITING

The Second Affiliated Hospital of Chongqing Medical University-Endocrinology

Chongqing, Chongqing Municipality, 400010, China

NOT YET RECRUITING

Chongqing University Three Gorges Hospital-Endocrinology

Chongqing, Chongqing Municipality, 404199, China

NOT YET RECRUITING

The Second People's Hospital of Shenzhen-Endocrinology

Shenzhen, Guangdong, 518035, China

NOT YET RECRUITING

Cangzhou People's Hospital-Endocrinology

Cangzhou, Hebei, 061000, China

NOT YET RECRUITING

Hebei PetroChina Central Hospital-Endocrinology

Langfang, Hebei, 065099, China

NOT YET RECRUITING

The Second Hospital of Hebei Medical University-Endocrinology

Shijiazhuang, Hebei, 050000, China

NOT YET RECRUITING

The First Hospital of Hebei Medical University-Endocrinology

Shijiazhuang, Hebei, 050023, China

NOT YET RECRUITING

Huaihe Hospital of Henan University-Endocrinology

Kaifeng, Henan, 475000, China

NOT YET RECRUITING

Luoyang First People's Hospital-Endocrinology

Luoyang, Henan, 471002, China

NOT YET RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology

Luoyang, Henan, 471003, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanyang Medical College-Endocrinology

Nanyang, Henan, 473058, China

NOT YET RECRUITING

The Second Affiliated Hospital of Zhengzhou University-Endocrinology

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University-Endocrinology

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)-Endocrinology

Shiyan, Hubei, 442008, China

NOT YET RECRUITING

The First People's Hospital of Changde City-Endocrinology

Changde, Hunan, 415003, China

NOT YET RECRUITING

The First People's Hospital of Changzhou-Endocrinology

Changzhou, Jiangsu, 213004, China

NOT YET RECRUITING

Changzhou No.2 People's Hospital-Endocrinology

Changzhou, Jiangsu, 213164, China

NOT YET RECRUITING

Nanjing First Hospital-Endocriniology

Nanjing, Jiangsu, 210006, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu, 210011, China

NOT YET RECRUITING

Nanjing Jiangning Hospital-Endocrinology

Nanjing, Jiangsu, 211199, China

NOT YET RECRUITING

The Second Affiliated Hospital of Soochow University-Endocrinology

Suzhou, Jiangsu, 215004, China

NOT YET RECRUITING

The Affiliated Hospital of Jiangsu University-Endocrinology

Zhenjiang, Jiangsu, 212001, China

NOT YET RECRUITING

The First Bethune hospital of Jilin University-Endocrinology

Changchun, Jilin, 130061, China

NOT YET RECRUITING

The Second Norman Bethune Hospital of Jilin University-Endocrinology

Jilin City, Jilin, 130041, China

NOT YET RECRUITING

Panjin Liaoyou Gemflower Hospital-Endocrinology

Panjin, Liaoning, 124120, China

NOT YET RECRUITING

Qinghai Provincial People's Hospital-Endocrinology

Xining, Qinghai, 810007, China

NOT YET RECRUITING

Jinan Central Hospital-General Medicine

Jinan, Shandong, 250013, China

NOT YET RECRUITING

Central Hospital of Minhang District, Shanghai-Endocrinology

Shanghai, Shanghai Municipality, 201199, China

NOT YET RECRUITING

Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Endocrinology

Chengdu, Sichuan, 610071, China

NOT YET RECRUITING

Huzhou Central Hospital-Endocrinology

Huzhou, Zhejiang, 313000, China

NOT YET RECRUITING

EFERTUS healthcare s.r.o.

Brno, 615 00, Czechia

NOT YET RECRUITING

Edumed s.r.o.

Broumov, 550 01, Czechia

NOT YET RECRUITING

Nemocnice Český Krumlov, a.s.

Český Krumlov, 381 01, Czechia

NOT YET RECRUITING

Poliklinika Dolní Břežany

Dolní Břežany, 252 41, Czechia

NOT YET RECRUITING

Medika Hradec Králové s.r.o.

Hradec Králové, 500 02, Czechia

NOT YET RECRUITING

Edumed s.r.o.

Náchod, 547 01, Czechia

NOT YET RECRUITING

MUDr. SRPOVÁ s.r.o.

Ostrava, 700 30, Czechia

NOT YET RECRUITING

Donmed s.r.o.

Ostrava, 710 00, Czechia

NOT YET RECRUITING

Pratia Pardubice a.s.

Pardubice, 530 02, Czechia

NOT YET RECRUITING

MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.

Pilsen, 326 00, Czechia

NOT YET RECRUITING

Medicon a.s.

Prague, 140 00, Czechia

NOT YET RECRUITING

IKEM

Prague, 140 21, Czechia

NOT YET RECRUITING

Diantel s.r.o.

Prague, 17000, Czechia

NOT YET RECRUITING

Medizinisches Versorgungszentrum Jung GbR

Deggingen, 73326, Germany

NOT YET RECRUITING

Praxis am Markt Dr. Becker

Essen, 45355, Germany

NOT YET RECRUITING

MVZ Diabeteszentrum Dr. Tews GmbH

Gelnhausen, 63571, Germany

NOT YET RECRUITING

Diabetes-Zentrum-Wilhelmsburg GbR

Hamburg, 21109, Germany

NOT YET RECRUITING

Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR

Hamburg, 22041, Germany

NOT YET RECRUITING

Dr. Milek medikum

Hohenmölsen, 06679, Germany

NOT YET RECRUITING

Praxisgemeinschaft Jerichow

Jerichow, 39319, Germany

NOT YET RECRUITING

Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut

Leipzig, 04249, Germany

NOT YET RECRUITING

Sanos Clinic GmbH Ratingen

Ratingen, 40882, Germany

NOT YET RECRUITING

Evangelismos S.A. - Endocrinology department

Athens, 10676, Greece

NOT YET RECRUITING

251 Air Force General Hospital - Department of Endocrinology & Diabetes

Athens, 115 25, Greece

NOT YET RECRUITING

Laiko General Hospital Of Athens - 1st department of Internal Medicine

Athens, 115 27, Greece

NOT YET RECRUITING

General Hospital Of Athens G Gennimatas - Department of Endocrinology

Athens, 11527, Greece

NOT YET RECRUITING

General Hospital Of Thessaloniki Papageorgiou - 3rd Department of Internal Medicine

Efkarpia, 564 29, Greece

NOT YET RECRUITING

University General Hospital Of Heraklion - Nephrology Department

Heraklion, 71500, Greece

NOT YET RECRUITING

Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department

Peristeri, 121 31, Greece

NOT YET RECRUITING

General University Hospital of Patras,Nephrology clinic

Rio, Patra, 26504, Greece

NOT YET RECRUITING

Ippokratio General Hospital Of Thessaloniki - 2nd Propaedeutic Department of Internal Medicine

Thessaloniki, 546 42, Greece

NOT YET RECRUITING

Ippokratio General Hospital Of Thessaloniki - B' Internal Medicine clinic

Thessaloniki, 546 42, Greece

NOT YET RECRUITING

Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department

Thessaloniki, 570 10, Greece

NOT YET RECRUITING

Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I - Nephrology Department

Νikaia, 184 54, Greece

NOT YET RECRUITING

Endolife Specialty Hospitals

Guntur, Andhra Pradesh, 522001, India

NOT YET RECRUITING

All India Institute of Medical Sciences (AIIMS), Raipur

Raipur, Chhattisgarh, 492099, India

NOT YET RECRUITING

Nirmal Hospital Pvt. Ltd.

Surat, Gujarat, 395001, India

NOT YET RECRUITING

SSG Hospital, Baroda

Vadodara, Gujarat, 390001, India

NOT YET RECRUITING

Life Care Hospital and Research Centre

Bangalore, Karnataka, 560092, India

NOT YET RECRUITING

Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala, 682041, India

NOT YET RECRUITING

Government Medical College, Kozhikode

Kozhikode, Kerala, 673008, India

NOT YET RECRUITING

TOTALL Diabetes Hormone Institute

Indore, Madhya Pradesh, 452010, India

NOT YET RECRUITING

BSES MG hospital

Mumbai, Maharashtra, 400058, India

NOT YET RECRUITING

Sunil's Diabetes Care n' Research Centre Pvt Ltd

Nagpur, Maharashtra, 440010, India

NOT YET RECRUITING

Chellaram Diabetes Institute

Pune, Maharashtra, 411021, India

NOT YET RECRUITING

Ashirwad Hospital and Research Centre

Thane, Maharashtra, 421004, India

NOT YET RECRUITING

All India Institute of Medical Sciences (AIIMS), Bhubaneswar

Bhubaneswar, Odisha, 751019, India

NOT YET RECRUITING

Deep Healthcare Private Limited.

Ludhiana, Punjab, 141002, India

NOT YET RECRUITING

Diabetes, Thyroid and Endocrine Centre

Jaipur, Rajasthan, 302006, India

NOT YET RECRUITING

KG Hospital and PG Medical Institute & Research Centre

Coimbatore, Tamil Nadu, 641018, India

NOT YET RECRUITING

Christian Medical College Hospital, Vellore

Vellore, Tamil Nadu, 632004, India

NOT YET RECRUITING

Osmania General Hospital_Hyderabad

Hyderabad, Telangana, 500012, India

NOT YET RECRUITING

NIZAM'S Institute of Medical Sciences

Hyderabad, Telangana, 500082, India

NOT YET RECRUITING

SMS Hospital

Jaipur, 302004, India

NOT YET RECRUITING

All India Institute of Medical Sciences (AIIMS)

New Delhi, 110029, India

NOT YET RECRUITING

Università degli studi G. D'Annunzio di Chieti - CAST - Centro Ricera Clinica (CRC)

Chieti, Abruzzo, 66100, Italy

NOT YET RECRUITING

AOU Renato Dulbecco - Unità Operativa Complessa Medicina Interna

Catanzaro, Calabria, 88100, Italy

NOT YET RECRUITING

AOU Federico II Di Napoli - DAI Endocr. Diab. Andro. e Nutr. - UOC Endocrinologia Diabetologia e Andrologia

Naples, Campania, 80131, Italy

NOT YET RECRUITING

AUSL Romagna - Medicine Specialistiche Ravenna - UO Servizio di Diabetologia di Ravenna

Ravenna, Emilia-Romagna, 48121, Italy

NOT YET RECRUITING

Polo Ospedaliero di Chiavari - S.S.D. Diabetologia e Malattia Metaboliche

Chiavari, Liguria, 16043, Italy

NOT YET RECRUITING

Ospedale San Raffaele S.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico

Milan, Lombardy, 20132, Italy

NOT YET RECRUITING

Policlinico Umberto I Seconda Clinica Medica

Roma, RM, 00161, Italy

NOT YET RECRUITING

AUSL Toscana Nord Ovest - Cittadella della Salute Campo di Marte - Diabetologia Lucca e Valle del Serchio

Lucca, Tuscany, 55100, Italy

NOT YET RECRUITING

ASST Santi Paolo e Carlo - Ospedale San Paolo - Diabetologia

Milan, 20142, Italy

NOT YET RECRUITING

Diseño y Planeación en Investigación Médica S.C.

Guadalajara, Jalisco, 44600, Mexico

NOT YET RECRUITING

Instituto Jalisciense de Investigación en Diabetes y Obesidad

Guadalajara, Jalisco, 44600, Mexico

NOT YET RECRUITING

Centro de Investigacion Clinica Endocrinologica de Jalisco

Guadalajara, Jalisco, 44670, Mexico

NOT YET RECRUITING

Instituto Nacional de Ciencias Médicas y Nutrición

Tlalpan, Mexico City, 14080, Mexico

NOT YET RECRUITING

Alliance CEINV Salud S.A. de C.V.

Monterrey, Nuevo León, 64020, Mexico

NOT YET RECRUITING

Investigación Médica Sonora S.C.

Hermosillo, Sonora, 83280, Mexico

NOT YET RECRUITING

Centro de Estudios de Investigación Metabólicos y Cardio

Ciudad Madero, Tamaulipas, 89440, Mexico

NOT YET RECRUITING

SIYODE S.A. de C.V. Unimeden

Ciudad Madero, Tamaulipas, 89450, Mexico

NOT YET RECRUITING

Centro de Desarrollo Biomédico S.C.P.

Merida Centro, Yucatán, 97070, Mexico

NOT YET RECRUITING

Medical Care and Research S. A de C.V

Mérida, Yucatán, 97070, Mexico

NOT YET RECRUITING

Zana-Med Medical Group Sp. z o.o.

Lublin, Lublin Voivodeship, 20-601, Poland

NOT YET RECRUITING

NZOZ Vita-Diabetica Malgorzata Buraczyk

Bialystok, Podlaskie Voivodeship, 15-879, Poland

NOT YET RECRUITING

M2M Med. Badania Sp. z o.o.

Chorzów, Silesian Voivodeship, 41-500, Poland

NOT YET RECRUITING

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-269, Poland

NOT YET RECRUITING

Osteo-Medic s.c. A. Racewicz, J. Supronik

Bialystok, 15-351, Poland

NOT YET RECRUITING

Kresmed Sp. z o. o.

Bialystok, 15-481, Poland

NOT YET RECRUITING

Zespol Opieki Zdrowotnej w Boleslawcu

Bolesławiec, 59-700, Poland

NOT YET RECRUITING

Diab Serwis Popenda Spółka Jawna

Chorzów, 41-516, Poland

NOT YET RECRUITING

Gyncentrum Sp. z o. o.

Katowice, 40-600, Poland

NOT YET RECRUITING

Centrum Medyczne MBB-MED Marta Blach-Burek

Libiąż, 32-590, Poland

NOT YET RECRUITING

Gabinet Lekarski Malgorzata Saryusz-Wolska

Lodz, 90-132, Poland

NOT YET RECRUITING

Amicare Sp. z o.o. S.K.

Lodz, 91-495, Poland

NOT YET RECRUITING

Velocity Nova Sp. z o.o.

Lublin, 20-362, Poland

NOT YET RECRUITING

Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.

Olsztyn, 10-117, Poland

NOT YET RECRUITING

Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.

Piotrkow Trybunalski, 97-300, Poland

NOT YET RECRUITING

Centrum Zdrowia Metabolicznego Paweł Bogdański

Poznan, 60-589, Poland

NOT YET RECRUITING

Maciej Wiza Gaja Poradnie Lekarskie

Poznan, 61-251, Poland

NOT YET RECRUITING

Velocity Nova Sp. z o.o.

Puławy, 24-100, Poland

NOT YET RECRUITING

Centrum Medyczne Medyk Sp.zo.o. Sp.k.

Rzeszów, 35-055, Poland

NOT YET RECRUITING

Medicover Integrated Clinical Services Sp. z o.o.

Torun, 87-100, Poland

NOT YET RECRUITING

Szpital Czerniakowski Sp. z o.o.

Warsaw, 00-739, Poland

NOT YET RECRUITING

PANSTWOWY INSTYTUT MEDYCZNY MSWiA

Warsaw, 02-507, Poland

NOT YET RECRUITING

Regionalna Poradnia Diabetologiczna-Zytkiewicz-Jaruga, Stasinska Spolka Partnerska Lekarzy

Wroclaw, 50-127, Poland

NOT YET RECRUITING

Velocity Nova Sp. z o.o.

Zamość, 22-400, Poland

NOT YET RECRUITING

Prywatna Praktyka Lekarska Anna Chudoba

Żyrardów, 96-300, Poland

NOT YET RECRUITING

CHUAC_Endocrinología

A Coruña, 15006, Spain

NOT YET RECRUITING

Hosp. Vall d'Hebrón_Endocrinología

Barcelona, 08035, Spain

NOT YET RECRUITING

Clinic Barcelona_Endocrinología

Barcelona, 08036, Spain

NOT YET RECRUITING

Hospital de Mostoles_Endocrinología

Móstoles, 28935, Spain

NOT YET RECRUITING

H Virgen del Camino_Sanlúcar_Medicina Interna

Sanlúcar de Barrameda, 11540, Spain

NOT YET RECRUITING

CHUS_Endocrinología

Santiago de Compostela, 15706, Spain

NOT YET RECRUITING

Hospital General de Segovia_Endocrinología

Segovia, 40002, Spain

NOT YET RECRUITING

Hospital General de Valencia_Endocrinología

Valencia, 46014, Spain

NOT YET RECRUITING

Erciyes Üniversitesi Hastanesi - Nefroloji

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

NOT YET RECRUITING

Adana Şehir Eğitim ve Araştırma Hastanesi

Adana, 01060, Turkey (Türkiye)

NOT YET RECRUITING

Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi -Endokrinoloji

Adana /yüreği̇r, 01240, Turkey (Türkiye)

NOT YET RECRUITING

Sakarya Egitim ve Arastirma Hastanesi-Nefroloji

Adapazarı/Turkiye, 54100, Turkey (Türkiye)

NOT YET RECRUITING

Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Nefroloji

Afyonkarahisar, 03200, Turkey (Türkiye)

NOT YET RECRUITING

Ankara Bilkent Şehir Hastanesi-Dahiliye

Ankara, 06800, Turkey (Türkiye)

NOT YET RECRUITING

Gaziantep Üniversitesi Hastanesi- Endokrinoloji

Gaziantep, 27070, Turkey (Türkiye)

NOT YET RECRUITING

Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye

Istanbul, 34722, Turkey (Türkiye)

NOT YET RECRUITING

Ege Üniversitesi Tip Fakultesi Hastanesi - Nefroloji

Izmir, 35100, Turkey (Türkiye)

NOT YET RECRUITING

Erciyes Üniversitesi Hastanesi- Kardiyoloji

Kayseri, 38039, Turkey (Türkiye)

NOT YET RECRUITING

Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji

Kocaeli, 41380, Turkey (Türkiye)

NOT YET RECRUITING

Bursa Yüksek İhtisas Eğitim ve Araştırma Merkezi-Endokrinoloji

Nilüfer/Bursa, 16140, Turkey (Türkiye)

NOT YET RECRUITING

Eskişehir Şehir Hastanesi- Kardiyoloji

Odunpazarı /Eskişehir, 26080, Turkey (Türkiye)

NOT YET RECRUITING

Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji

Sivas, 58140, Turkey (Türkiye)

NOT YET RECRUITING

Dicle Üniversitesi Tıp Fakültesi Sağlık Ve Araştırma Hastanesi- Nefroloji

Sur / Diyarbakır, 21280, Turkey (Türkiye)

NOT YET RECRUITING

North Coast Medical Ltd

Newquay, Cornwall, TR7 1RU, United Kingdom

NOT YET RECRUITING

Yeovil Hospital

Yeovil, Somerset, BA21 4AT, United Kingdom

NOT YET RECRUITING

Clifton Medical Centre

Rotherham, South Yorkshire, S65 1DA, United Kingdom

NOT YET RECRUITING

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

NOT YET RECRUITING

University Hospital Coventry - WISDEM Centre

Coventry, CV2 2DX, United Kingdom

NOT YET RECRUITING

Hull Royal Infirmary - Diabetes

Hull, HU3 2JZ, United Kingdom

NOT YET RECRUITING

Ipswich Hospital - Diabetes

Ipswich, IP4 5PD, United Kingdom

NOT YET RECRUITING

Altnagelvin Area Hospital

Londonderry, BT47 6SB, United Kingdom

NOT YET RECRUITING

Joint Clinical Research Facility - Swansea

Swansea, SA2 8PP, United Kingdom

NOT YET RECRUITING

Egremont Medical Centre

Wallasey, CH44 8AT, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2026

First Posted

September 1, 2026

Study Start

August 24, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

September 20, 2028

Last Updated

September 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

According to the Novo Nordisk disclosure commitment on novonordisktrials.com

More information

Locations