ZENAGAMTIDE for Overweight | Obesity | Type 2 diabetes

Inclusion criteria

• {"criterion_text":"- 1. Male or female (sex at birth)"}
• {"criterion_text":"- 2. Age 18 years or above at the time of signing informed consent"}
• {"criterion_text":"- 3. BMI ≥ CCI kg/m2 at screening"}
• {"criterion_text":"- 4. CCI"}
• {"criterion_text":"- 5. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening."}
• {"criterion_text":"- 6. Haemoglobin A1c (HbA1c) 7-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening."}
• {"criterion_text":"- 7. Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least CCI days before screening."}

Exclusion criteria

• {"criterion_text":"- 1. Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 (2021 CKD-EPI formula), at screening."}
• {"criterion_text":"- 2. 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 randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination."}
• {"criterion_text":"- 3. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 8."}
• {"criterion_text":"- 4. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator."}
• {"criterion_text":"- 5. 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 within CCI before screening."}

Primary endpoints

• {"endpoint_text":"- Relative change in body weight","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in haemoglobin A1c (HbA1c)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in waist circumference","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in systolic blood pressure (SBP):","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in body weight","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in body mass index (BMI)","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- Achievement of HbA1c < 7.0% (Yes/No)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Achievement of HbA1c ≤ 6.5% (Yes/No)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Achievement of HbA1c < 5.7% (Yes/No)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in fasting plasma glucose (FPG)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in fasting insulin","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in urinary albumin-to-creatinine ratio (UACR)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in diastolic blood pressure (DBP)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in high-sensitivity C-reactive protein (hsCRP)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of Treatment Emergent Adverse Events (TEAEs)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of Treatment Emergent Serious Adverse Events (TESAEs)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of TEAEs leading to permanent treatment discontinuation","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose (BG) meter)","definition_or_measurement_approach":"< 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose (BG) meter"}
• {"endpoint_text":"- Number of treatment-emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold","definition_or_measurement_approach":"Hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold"}
• {"endpoint_text":"- Extension phase secondary endpoints are as follows; Change in body weight","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in body mass index (BMI)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of TEAEs","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of TESAEs","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of TEAEs leading to permanent treatment discontinuation","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by BG meter)","definition_or_measurement_approach":"< 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose (BG) meter"}
• {"endpoint_text":"- Number of treatment-emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold","definition_or_measurement_approach":"Hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold"}

Methods

• Google Ads campaign (German materials listed: 'k2_de_nn9490-8028-recruitment-material-google-ads-campaign-german') — digital advertising targeting German-speaking participants
• Meta (Facebook/Instagram) Ads campaign (German materials listed: 'k2_de_nn9490-8028-recruitment-material-meta-ads-campaign-german') — digital advertising targeting German-speaking participants
• Online questionnaire (German) ('k2_de_nn9490-8028-recruitment-material-online-questionnaire-german') — digital pre-screening tool for prospective participants in Germany
• Recruitment poster and flyers (German and Portuguese) ('k2_de_nn9490-8028-recruitment-material-recruitment-poster-german', 'k2-pt-nn9490-8028-recruitment-advertisement-poster-portuguese') — local site/community materials
• Video script (German) ('k2_de_nn9490-8028-recruitment-material-video-script-german') — multimedia recruitment content for Germany
• Website (German) ('k2_de_nn9490-8028-recruitment-material-website-german') — online study information for German audience
• PI-to-patient patient letter and PI-to-physician doctors' letter (German) ('k2_de_nn9490-8028-recruitment-material-pi-to-patient-patient-letter-content-german', 'k2_de_nn9490-8028-recruitment-material-pi-to-physician-doctors-letter-content-german') — clinician-mediated recruitment in Germany
• Patient information service (German) ('k2_de_nn9490-8028-recruitment-material-patient-information-service-german') — channel for patient inquiries in Germany
• Direct-to-patient services via vendor (role identified for Marken Limited as 'Direct to patient') — supports direct distribution/engagement with patients
• Local site recruitment through hospital/clinic sites and patient organisations (e.g., APDP in Portugal listed as a trial site) — country-specific community/organisation outreach

Germany

Earliest CTIS Part Ii Submission Date

20-04-2026

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

25

Number Of Sites

10

Number Of Participants

45

Portugal

Earliest CTIS Part Ii Submission Date

06-03-2026

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

70

Number Of Sites

8

Number Of Participants

40

Primary sponsor

Full Name

Novo Nordisk A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

4G Clinical B.V.

Responsibilities

RTSM/IWRS supplier

Name

Icon Clinical Research Limited

Responsibilities

Imaging; Central Laboratory

Name

Iqvia Biotech Limited

Responsibilities

eCOA

Name

Celerion Switzerland AG

Responsibilities

Laboratory analysis

Name

Marken Limited

Responsibilities

Direct to patient

Name

Veeva Systems Inc.

Responsibilities

CRF supplier. Global Safety Database supplier

Third parties

• {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM/IWRS supplier","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"Laboratory analysis","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Marken Limited","duties_or_roles":"Direct to patient","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"CRF supplier. Global Safety Database supplier","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Roche Diabetes Care Inc.","duties_or_roles":"Blood Glucose Meter","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}