A Research Study Investigating How Well Zenagamtide Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise (AMBITION 1)

November 6, 2026 updated by: Novo Nordisk A/S

Efficacy and Safety of Zenagamtide s.c. Once Weekly Compared to Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Diet and Exercise

This study is being done to look at how well zenagamtide lowers blood sugar levels and body weight in people with type 2 diabetes when compared to placebo. Participants will either get zenagamtide, the treatment being tested or placebo, a treatment that has no active medicine in it. 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 404199
        • Chongqing University Three Gorges Hospital-Endocrinology
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
      • Zhenjiang, Jiangsu, China, 212001
        • The Affiliated Hospital of Jiangsu University-Endocrinology
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital-General Medicine
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300134
        • Tianjin Medical University Chu Hsien-I Memorial Hospital-Department of Metabolism
  • Japan
      • Chiba-shi, Chiba, Japan, 260-0804
        • Akaicho Clinic_Internal medicine
      • Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic_Internal Medicine
      • Tokyo, Japan, 104-0031
        • Fukuwa Clinic_Internal Medicine
      • Tokyo, Japan, 160-0008
        • ToCROM Clinic_Internal Medicine
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0853
        • OCROM Clinic_Internal medicine
  • Poland
      • Katowice, Poland, 40-648
        • Pro Familia Altera Sp. z o.o.
      • Malbork, Poland, 82-200
        • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
      • Oświęcim, Poland, 32-600
        • Formed 2 Sp. z o.o.
      • Staszów, Poland, 28-200
        • Velocity Nova Sp. z o.o.
      • Warsaw, Poland, 00-710
        • NBR Polska Tomasz Klodawski
      • Świnoujście, Poland, 72-600
        • Balticmed Świnoujście Sp. z o. o.
    • Masovian Voivodeship
      • Płock, Masovian Voivodeship, Poland, 09-407
        • Cbk Med Clinic Sp. z o.o.
  • Puerto Rico
      • San Juan, Puerto Rico, 00907
        • Solace Clinical Research
  • Romania
      • Bucharest, Romania, 013764
        • SC Nutrilife SRL
      • Bucharest, Romania, 050159
        • Institutul De Pneumoftiziologie Marius Nasta
      • Sibiu, Romania, 550371
        • SC Gensan SRL, Policlinica ASTRA
    • Bihor County
      • Oradea, Bihor County, Romania, 410147
        • Diabdana S.R.L.
    • Mureș County
      • Reghin, Mureș County, Romania, 545300
        • Poli Cardinal Med Srl
      • Târgu Mureş, Mureș County, Romania, 540142
        • Sc Mediab Srl
  • Slovakia
      • Bratislava, Slovakia, 84108
        • KARDIO-SANUS, spol. s r.o.
      • Bytča, Slovakia, 014 01
        • Diab - Int, s.r.o.
      • Košice, Slovakia, 040 01
        • Univerzitna nemocnica L. Pasteura Kosice
      • Nové Zámky, Slovakia, 940 59
        • FUNKYSTUFF s.r.o
      • Trnava, Slovakia, 91701
        • JAL s.r.o.
      • Šurany, Slovakia, 942 01
        • DEImedi, s. r. o.
  • Turkey (Türkiye)
      • Adapazarı/Sakarya, Turkey (Türkiye), 54100
        • Sakarya Eğitim ve Araştırma Hastanesi- Dahiliye
      • Ankara, Turkey (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi-Dahiliye
      • Bursa, Turkey (Türkiye), 16250
        • Bursa Şehir Hastanesi- Dahiliye
      • Giresun, Turkey (Türkiye), 28100
        • Giresun Eğitim ve Araştırma Hastanesi-Dahiliye
      • Istanbul, Turkey (Türkiye), 34722
        • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Aile Hekimliği
      • Yuregir/Adana, Turkey (Türkiye), 01060
        • Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Ark Clinical Research
      • Los Angeles, California, United States, 90015
        • Los Angeles Institute for Metabolic Research
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research_Spring Valley
    • Florida
      • Hollywood, Florida, United States, 33024
        • Encore Medical Research LLC
      • Miami, Florida, United States, 33155
        • My Preferred Research
      • Orlando, Florida, United States, 32825
        • Florida Institute for Clinical research
      • Weston, Florida, United States, 33331
        • Encore Medical Research of Weston
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Accellacare
    • Pennsylvania
      • Washington, Pennsylvania, United States, 15301
        • Preferred Primary Care physicians Washington
    • Texas
      • Houston, Texas, United States, 77081
        • Southwest Clinical Trials
      • San Antonio, Texas, United States, 78222
        • Pinnacle Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 informed consent.
  • Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 30 days before screening.
  • Treatment naïve to any glucose-lowering medication(s).

Exclusion criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
  • Current treatment or history of treatment with any medication for the indication of diabetes, or 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 for any indication. However, previous insulin treatment during Gestational Diabetes Mellitus is allowed.
  • Treatment with any medication for the indication of obesity 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. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated 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 (NYHA) Class IV at screening.
  • Planned coronary, carotid or peripheral artery revascularisation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo

Participants will receive placebo matched to zenagamtide subcutaneously.
Drug: Placebo

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

Participants will receive zenagamtide subcutaneously.
Drug: Zenagamtide

Zenagamtide will be administered subcutaneously once weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycated haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to week 44

Measured as percentage (%) - points.
From baseline (week 0) to week 44

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From baseline (week 0) to week 44

Measured as %.
From baseline (week 0) to week 44
Change in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo)
Time Frame: From baseline (week 0) to week 44

Measured as ratio to baseline.
From baseline (week 0) to week 44
Change in triglycerides
Time Frame: From baseline (week 0) to week 44

Measured as ratio to baseline.
From baseline (week 0) to week 44
Change in non-high-density lipoprotein (non-HDL) cholesterol
Time Frame: From baseline (week 0) to week 44

Measured as ratio to baseline.
From baseline (week 0) to week 44
Change in high sensitivity C-reactive protein (hsCRP)
Time Frame: From baseline (week 0) to week 44

Measured as ratio to baseline.
From baseline (week 0) to week 44
Change in 7-point self-measured plasma glucose (SMPG) profiles: Mean postprandial increment (over all meals)
Time Frame: From baseline (week 0) to week 44

Measured as millimoles per liter (mmol/L).
From baseline (week 0) to week 44
Change in systolic blood pressure
Time Frame: From baseline (week 0) to week 44

Measured as millimeters of mercury (mmHg).
From baseline (week 0) to week 44

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 10, 2026

Primary Completion (Estimated)

June 5, 2028

Study Completion (Estimated)

August 28, 2028

Study Registration Dates

First Submitted

November 6, 2026

First Submitted That Met QC Criteria

November 6, 2026

First Posted (Actual)

November 12, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 6, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9489-8033
  • U1111-1335-3191 (Other Identifier: World Health Organization (WHO))
  • 2026-525470-18 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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