Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Starting soon Phase 3

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

NCT07931547 · tracked via the Priya Life Science Brazil tracker
Phase
Phase 3
Started
2026-11-10
Last updated
2026-11-12

Condition(s) studied

Type 2 DiabetesChronic Kidney Disease

Investigational drug(s) / intervention(s)

PlaceboZenagamtide →

Placebo: Placebo matched to zenagamtide will be administered subcutaneously once weekly.

Zenagamtide: Zenagamtide will be administered subcutaneously once weekly.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in glycated haemoglobin (HbA1c) — From baseline (week 0) to week 52
    Measured in percentage (%)-points

Trial sites (125)

FacilityCityRegionStatus
Scripps Whittier Diabetes Inst La Jolla California
First Valley Medical Group Lancaster California
Headlands Research CTR Lincoln Lincoln California
North America Research Institute San Dimas California
Northeast Research Institute Fleming Island Florida
Encore Medical Research LLC Hollywood Florida
My Preferred Research Miami Florida
Adult Medicine of Lake County, Inc Mt. Dora Florida
West Orange Endocrinology Ocoee Florida
Florida Inst For Clin Res LLC Orlando Florida
Care Access Tamarac Florida
Encore Medical Research of Weston Weston Florida
Palm Research Center Inc-Vegas Las Vegas Nevada
DM Clinical Brooklyn New York
University of North Carolina Chapel Hill Chapel Hill North Carolina
Carteret Medical Group Morehead City North Carolina
Spartanburg Medical Research Spartanburg South Carolina
Holston Medical Group Pc Bristol Tennessee
Southeast Renal Research Institute Chattanooga Tennessee
Clinical Research Associates Nashville Tennessee
Victorium Clinical Research Houston Texas
Prolato Clinical Research Cntr Houston Texas
Southwest Clinical Trials Houston Texas
Medical Colleagues-Texas LLP Katy Texas
Northeast Clinical Research of San Antonio San Antonio Texas
Consano Clinical Research, LLC Shavano Park Texas
Hospital de Clínicas de Porto Alegre_Porto Alegre Porto Alegre Rio Grande do Sul
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda. Porto Alegre Rio Grande do Sul
Instituto de Pesquisa Clínica de Campinas Campinas São Paulo
CPQuali Pesquisa Clínica Ltda São Paulo São Paulo
The Second People's Hospital of Hefei-Endocrinology Hefei Anhui
Chongqing University Three Gorges Hospital-Endocrinology Chongqing Chongqing Municipality
Huizhou Central People's Hospital-Endocrinology Huizhou Guangdong
The Second People's Hospital of Shenzhen-Endocrinology Shenzhen Guangdong
Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology Hengshui Hebei
The Second Hospital of Hebei Medical University-Endocrinology Shijiazhuang Hebei
Huaihe Hospital of Henan University-Endocrinology Kaifeng Henan
Luoyang First People's Hospital-Endocrinology Luoyang Henan
The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology Luoyang Henan
The First Affiliated Hospital of Nanyang Medical College-Endocrinology Nanyang Henan

+ 85 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07931547 on ClinicalTrials.gov ↗ ← All trials in Brazil