ClinicalTrials.gg
Not yet recruitingNCT07931573AMBITION 3Updated Nov 12, 2026

AMBITION 3: A Research Study Investigating How Well Zenagamtide at Higher Dose Levels Lowers Blood Sugar and Body Weight Compared to Semaglutide in People With Type 2 Diabetes Treated With Metformin, SGLT2i, or Both

A Phase 3 interventional study of Zenagamtide and Semaglutide in Type 2 Diabetes, sponsored by Novo Nordisk A/S. Not yet recruiting at 230 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 643 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S — 25 open to participants now, 29 under way, 11 of them phase 3. Diabetes Mellitus, Type 2 · Novo Nordisk A/S.

Planned enrollment
26th of 428
1,200 · median 209
Started
2026
with 22 others
Phase 3
187 of 643
8 open now
Primary completion
2028-07
later than 18 of 28 live
Registered
640th of 643
by date

Among the 643 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S, this one is the 26th largest by planned enrollment of the 428 interventional ones that give a count, is one of 23 that started in 2026, is one of 187 in phase 3, reaches primary completion later than 18 of the 28 other live ones, and was the 640th registered.

Diabetes Mellitus, Type 2

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 →

Open to participants now

25 of the 643 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S are open now, in 12 countries. Recruiting first, the newest first:

20 more — sign in →

By country, each count listing its studies:

All 25 open studies →

Who these studies take

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: 18 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.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 643 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S, or all of them as a file.
02

Study summary

The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will get one of the following: Zenagamtide (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator).

03

Conditions studied

  • Type 2 Diabetes
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Male or female (sex assigned at birth, inclusive of all gender identities).
  • Age 18 years or above at the time of signing the .
  • Diagnosed with type 2 diabetes (T2D) above or equal to 180 days before screening.
  • On stable daily dose(s) of metformin, sodium-glucose transport 2 (SGLT2) inhibitor, or both (at effective or maximum tolerated dose as judged by the investigator) prior to screening.
  • (HbA1c) as determined by central laboratory at screening.

Exclusion criteria

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of and not using adequate method.
  • Myocardial infarction, stroke, or hospitalisation for unstable angina pectoris within 60 days before screening.
  • Chronic heart failure classified as being in (NYHA) Class IV at screening.
  • Planned coronary, carotid or peripheral artery revascularisation.
  • 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 is allowed as well as short term insulin treatment for a maximum of 14 consecutive days.
  • 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 (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 within 90 days before screening or in the period between screening and randomisation.

Terms in these criteria, in plain language(6)

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.

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.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    Zenagamtide

    Participants will receive zenagamtide subcutaneously once weekly

    Drug: Zenagamtide

  • Active comparator
    Semaglutide

    Participants will receive semaglutide subcutaneously once weekly

    Drug: Semaglutide

  • Placebo comparator
    Placebo

    Participants will receive placebo matched to semaglutide or zenagamtide subcutaneously once weekly

    Drug: Placebo

Interventions

  • DrugZenagamtide

    Zenagamtide will be administered subcutaneously

  • DrugSemaglutide

    Semaglutide will be administered subcutaneously

  • DrugPlacebo

    Placebo matched to semaglutide or zenagamtide will be administered subcutaneously

06

What researchers measure

Primary outcomes

  1. Change in glycated haemoglobin (HbA1c) [non-inferiority]

    Measured in percentage point

    Time frame: From baseline (week 0) to week 60

Secondary outcomes

  1. Relative change in body weight

    Measured in percentage

    Time frame: From baseline (week 0) to week 60

  2. Change in glycated haemoglobin (HbA1c) [superiority]

    Measured in percentage point

    Time frame: From baseline (week 0) to week 60

  3. Change in triglycerides

    Measured in ratio to baseline

    Time frame: From baseline (week 0) to week 60

  4. Change in systolic blood pressure

    Measured in mmHg

    Time frame: From baseline (week 0) to week 60

  5. Change in non-high density lipoprotein (non-HDL) cholesterol

    Measured in ratio to baseline

    Time frame: From baseline (week 0) to week 60

  6. Change in high-sensitivity C-reactive protein (hsCRP)

    Measured in ratio to baseline

    Time frame: From baseline (week 0) to week 60

07

Study locations

230 sites

Showing the first 100 of 230 sites across 22 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Data sharing details ↗ · novonordisk-trials.com

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jul 2028, 19 months later.

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 19 months is close to 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.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Nov 10, 2026
Primary completionEst.
Jul 4, 2028
CompletionEst.
Aug 8, 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07931573
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Jul 4, 2028 (estimated)
Completion
Aug 8, 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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