ZENAGAMTIDE for Overweight or obesity|Type 2 diabetes

Inclusion criteria

• {"criterion_text":"- 1. Male or female (sex at birth).\n- 2. Age 18 years or above at the time of signing informed consent.\n- 3. BMI CCI kg/m2.\n- 4. CCI\n- 5. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.\n- 6. 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 before screening.\n- 7. Haemoglobin A1c (HbA1c) 7-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at 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.\n- 2. Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within180 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.\n- 3. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question.\n- 4. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.\n- 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 waist circumference","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in haemoglobin A1c (HbA1c)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in systolic blood pressure (SBP)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning scorea","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","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":"- Change in IWQOL-Lite-CT Physical Psychosocial Total score","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","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","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":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","definition_or_measurement_approach":""}
• {"endpoint_text":"- CCI","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 Treatment Emergent Adverse Events (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 (no specific glucose threshold)"}

Methods

• Country-specific recruitment arrangements and recruitment posters (documents k1/k2) available for Croatia, Hungary, Italy, Romania, Slovakia (advertisement posters and recruitment arrangements documents referenced in CTIS documents list).
• Direct-to-patient recruitment and supply (Marken Limited listed with role 'Direct to patient').
• Home delivery option referenced in Italian subject information document (l1_it-nn9490-8024-piic-home-delivery).

Croatia

Earliest CTIS Part Ii Submission Date

27-04-2026

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

14

Number Of Sites

8

Number Of Participants

40

Italy

Earliest CTIS Part Ii Submission Date

02-02-2026

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

93

Number Of Sites

6

Number Of Participants

30

Romania

Earliest CTIS Part Ii Submission Date

03-04-2026

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

38

Number Of Sites

9

Number Of Participants

80

Slovakia

Earliest CTIS Part Ii Submission Date

07-04-2026

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

27

Number Of Sites

6

Number Of Participants

50

Primary sponsor

Full Name

Novo Nordisk A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Central Laboratory

Name

IQVIA Limited

Responsibilities

eCOA; Continued Glucose Monitoring; supplier support

Name

4G Clinical B.V.

Responsibilities

RTSM/IWRS supplier and RTSM/IWRS helpdesk

Name

Celerion Switzerland AG

Responsibilities

support role (code:4)

Name

SYRINX Bioanalytics Oy

Responsibilities

support role (code:4)

Name

Nordic Bioscience A/S

Responsibilities

laboratory support (code:4)

Third parties

• {"country":"Finland","full_name":"SYRINX Bioanalytics Oy","duties_or_roles":"code:4","organisation_type":"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"}
• {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"CRF supplier and Global Safety Database supplier","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM/IWRS supplier and RTSM/IWRS helpdesk","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited (Continued Glucose Monitoring)","duties_or_roles":"Continued Glucose Monitoring","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Marken Limited","duties_or_roles":"Direct to patient","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Nordic Bioscience A/S (laboratory role)","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Marken Limited (direct-to-patient)","duties_or_roles":"Direct to patient","organisation_type":"Pharmaceutical company"}