A Phase 3 interventional study of Zenagamtide and Insulin glargine U-100 in Type 2 Diabetes and Cardiovascular Risk, sponsored by Novo Nordisk A/S. Recruiting at 330 sites in 16 countries. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
Among 638 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S — 21 open to participants now, 25 under way, 7 of them phase 3. Diabetes Mellitus, Type 2 · Novo Nordisk A/S.
Among the 638 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S, this one is the 15th largest by planned enrollment of the 423 interventional ones that give a count, is one of 19 that started in 2026, is one of 183 in phase 3, reaches primary completion later than 17 of the 24 other live ones, and was the 634th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →21 of the 638 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S are open now, in 12 countries. Recruiting first, the newest first:
Novo Nordisk A/S · Sites in Germany
Novo Nordisk A/S · Sites in United States
Novo Nordisk A/S · Sites in United States
Novo Nordisk A/S · Sites in United States
Novo Nordisk A/S · Sites in United States, Argentina, Brazil and 7 more countries
By country, each count listing its studies:
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 45 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
638 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 19 started in 2026.
This study's planned enrollment of 1,778 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 205 across the 423 interventional studies, 938 across the 215 observational. Of the 602 that completed or were terminated, 174 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
8 of the studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07220759Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide | 2027-05-12 |
| NCT07817251Phase 3Novo Nordisk A/SResearch Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema | 2027-06-09 |
| NCT03811561Phase 3Novo Nordisk A/SA Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes | 2027-11-07 |
| NCT05689372Novo Nordisk A/SRegulatory Post Marketing Surveillance (rPMS) Study of Ozempic (Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea | 2026-11-30 |
| NCT07532863Novo Nordisk A/SA Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants | 2027-03-27 |
Among the 638 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Documented coronary artery disease defined by at least one of the following:
-≥ 50% stenosis of coronary artery on angiography or other imaging modality.
Exclusion Criteria:
Diabetes- or weight related:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive zenagamtide subcutaneously once weekly to one of the body parts: thigh, abdomen or upper arm.
Drug: Zenagamtide
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
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).
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).
Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c)
Measured as percentage (%)-points
Time frame: From baseline (week 0) to week 52
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
Measured as days
Time frame: From baseline (week 0) to 104 weeks or more
Relative change in body weight
Measured as percentage (%) change
Time frame: From baseline (week 0) to week 52
Superiority of zenagamtide versus insulin: Change in HbA1c
Measured as %-points
Time frame: 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
Measured as Days
Time frame: From baseline (week 0) to 104 weeks or more
Change in waist circumference
Measured as centimeters
Time frame: From baseline (week 0) to week 52
Change in systolic blood pressure
Measured as millimeters of mercury (mmHg)
Time frame: From baseline (week 0) to week 52
Change in high-sensitivity C-reactive protein (hsCRP)
Measured as ratio to baseline
Time frame: From baseline (week 0) to week 52
Change in Triglycerides
Measured as ratio to baseline
Time frame: From baseline (week 0) to week 52
Change in Non-high-density lipoprotein (non-HDL) cholesterol
Measured as ratio to baseline
Time frame: From baseline (week 0) to week 52
Showing the first 100 of 330 sites across 16 countries. Choose a country and city above to see the rest.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisktrials.com
Data sharing details ↗ · novonordisk-trials.com
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jul 2028, 23 months after the start.
Of 438 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's planned 23 months is above that.
Counting every sponsor, half of 525 studies reached it within 20 months; a quarter within 14 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Zenagamtide