ZENAGAMTIDE for Overweight|Obesity|Obstructive sleep apnoea

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. CCI"}
• {"criterion_text":"- 4. CCI"}
• {"criterion_text":"- 5. Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening."}

Exclusion criteria

• {"criterion_text":"- 1. Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening."}
• {"criterion_text":"- 2. History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records."}
• {"criterion_text":"- 3. Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy."}
• {"criterion_text":"- 4. Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence."}
• {"criterion_text":"- 5. Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (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":""}
• {"endpoint_text":"- Change in apnoea-hypopnoea index (AHI)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Relative change in AHI","definition_or_measurement_approach":""}
• {"endpoint_text":"- Achievement of 50% reduction in AHI (Yes/No)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Achievement of: AHI < 5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in sleep apnoea specific hypoxic burden (SASHB)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in ESS score","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score","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":"- Improvement in obstructive sleep apnoea (OSA) severity category AHI < 5/hour = normal (Yes/No) ≥ 5 and < 15/hour = mild (Yes/No) ≥ 15 and < 30/hour = moderate (Yes/No) ≥ 30/hour = severe (Yes/No)","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 neck circumference","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in systolic blood pressure (SBP)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in diastolic blood pressure (DBP)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in high-sensitivity C-reactive protein (hsCRP)","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 fasting plasma glucose","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in glycated haemoglobin (HbA1c)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of: Treatment-Emergent Adverse Events (TEAEs) Treatment-Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation","definition_or_measurement_approach":""}

Methods

• Direct to patient (Marken Limited) - 'Direct to patient' activities listed in sponsor third-party duties; global/direct-to-patient recruitment channel mentioned
• Digital recruitment (Spain) - recruitment-material-web, recruitment-material-reel, recruitment-material-carousel (documents indicate web and social media materials for Spain)
• Patient-association recruitment (Spain) - 'recruitment-material-patient-association-poster-spanish' document indicating use of patient association materials
• Site-based recruitment (Germany) - site-specific recruitment materials and recruitment-arrangements documents for Germany (k1_de and k2_de documents)
• Local-language recruitment materials and posters (Denmark, Poland, Germany, Spain) - country-specific recruitment-arrangement and recruitment-poster documents exist for DK, DE, ES, PL

Denmark

Earliest CTIS Part Ii Submission Date

13-03-2026

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

17

Number Of Sites

2

Number Of Participants

25

Germany

Earliest CTIS Part Ii Submission Date

26-01-2026

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

64

Number Of Sites

6

Number Of Participants

30

Spain

Earliest CTIS Part Ii Submission Date

06-02-2026

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

52

Number Of Sites

9

Number Of Participants

35

Poland

Earliest CTIS Part Ii Submission Date

05-03-2026

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

35

Number Of Sites

9

Number Of Participants

35

Primary sponsor

Full Name

Novo Nordisk A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

IQVIA Limited

Responsibilities

WatchPAT300

Name

Icon Clinical Research Limited

Responsibilities

Central Laboratory; Imaging

Third parties

• {"country":"United Kingdom","full_name":"Marken Limited","duties_or_roles":"Direct to patient","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"WatchPAT300","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Central Laboratory","organisation_type":"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 States","full_name":"Veeva Systems Inc.","duties_or_roles":"CRF supplier and Global Safety Database supplier","organisation_type":"Non-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":"Roche Diabetes Care Inc.","duties_or_roles":"Blood Glucose Meter","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Austria","full_name":"The Siesta Group Schlafanalyse GmbH","duties_or_roles":"Polysomnography (PSG)","organisation_type":"Laboratory/Research/Testing facility"}