Clinical trial • Phase III • Endocrinology|Respiratory
ZENAGAMTIDE for Overweight or obesity|Obstructive sleep apnoea
Phase III trial of ZENAGAMTIDE for Overweight or obesity|Obstructive sleep apnoea.
Overview
- Trial Therapeutic Area
- Endocrinology|Respiratory
- Trial Disease
- Overweight or obesity|Obstructive sleep apnoea
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 02-12-2025
- First CTIS Authorization Date
- 24-03-2026
Trial design
Placebo - productName 'Placebo' (no dose or schedule specified)-controlled Phase III trial in Germany, Spain, Poland.
- Comparator
- Placebo - productName 'Placebo' (no dose or schedule specified)
- Target Sample Size
- 185
Eligibility
Recruits 185 No vulnerable populations selected; participants must be age 18 years or above at the time of signing informed consent. Consent is provided by the participant; no assent procedures or other vulnerable population procedures are described..
- Vulnerable Population
- No vulnerable populations selected; participants must be age 18 years or above at the time of signing informed consent. Consent is provided by the participant; no assent procedures or other vulnerable population procedures are described.
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":"- 3. 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."}
Endpoints
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":"- Withdrawal of positive airway pressure (PAP) therapy (Yes/No)","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":""}
Recruitment
- Registry Or Advocacy Recruitment
- True - patient association (unspecified, referenced in Spanish recruitment materials)
- Digital Remote Recruitment
- True - web-based materials, reels, carousel and other digital recruitment materials referenced (Spain); direct-to-patient digital channels indicated
- Planned Sample Size
- 185
- Recruitment Window Months
- 27
- Consent Approach
- Participants aged 18 years or above provide informed consent. Subject information and informed consent forms are available in country-specific languages (German, Spanish, Polish) including adult PIIC documents and male partner forms; direct-to-patient consent materials referenced for some countries.
Methods
- Direct to patient (via Marken Limited)
- Country-specific recruitment materials (posters, site materials) for Germany
- Digital recruitment materials: web, social media reels, carousel (Spain)
- Patient-association outreach (Spain)
- Home delivery and direct-to-patient options described in country documents (Poland)
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 115
Germany
- Earliest CTIS Part Ii Submission Date
- 03-03-2026
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 21
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- Siteworks GmbH
- Department Name
- Siteworks Prüfzentrum Schleswig | RespiRatio
- Principal Investigator Name
- Andreas Deimling
- Principal Investigator Email
- deimling.andreas@gmx.de
- Contact Person Name
- Andreas Deimling
- Contact Person Email
- deimling.andreas@gmx.de
- Site Name
- Diabeteszentrum Hamburg West (DZHW) Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle
- Department Name
- Wendisch/Dahl Hamburg (DZHW)
- Principal Investigator Name
- Dominik Dahl
- Principal Investigator Email
- dr.dahl@dzhw.de
- Contact Person Name
- Dominik Dahl
- Contact Person Email
- dr.dahl@dzhw.de
- Site Name
- Siteworks GmbH
- Department Name
- Siteworks - Zentrum für klinische Studien Bochum
- Principal Investigator Name
- Annemone Köchel
- Principal Investigator Email
- koechel@siteworks-research.de
- Contact Person Name
- Annemone Köchel
- Contact Person Email
- koechel@siteworks-research.de
- Site Name
- Institut fuer Diabetesforschung Muenster GmbH
- Principal Investigator Name
- Ludger Rose
- Principal Investigator Email
- l.rose@diabetes-muenster.de
- Contact Person Name
- Ludger Rose
- Contact Person Email
- l.rose@diabetes-muenster.de
- Site Name
- Siteworks GmbH
- Department Name
- Siteworks - Zentrum für klinische Studien Hannover
- Principal Investigator Name
- Ulrike Lengler
- Principal Investigator Email
- lengler@siteworks-research.de
- Contact Person Name
- Ulrike Lengler
- Contact Person Email
- lengler@siteworks-research.de
- Site Name
- Siteworks GmbH
- Department Name
- Siteworks - Zentrum für klinische Studien Karlsruhe
- Principal Investigator Name
- Julia Chevts
- Principal Investigator Email
- chevts@siteworks-research.de
- Contact Person Name
- Julia Chevts
- Contact Person Email
- chevts@siteworks-research.de
Spain
- Earliest CTIS Part Ii Submission Date
- 03-02-2026
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 52
- Number Of Sites
- 10
- Number Of Participants
- 30
Sites
- Site Name
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Principal Investigator Name
- Andreea Ciudin
- Principal Investigator Email
- andreea.ciudin@vallhebron.cat
- Contact Person Name
- Andreea Ciudin
- Contact Person Email
- andreea.ciudin@vallhebron.cat
- Site Name
- Asociacion Instituto De Investigacion Sanitaria Bioaraba
- Principal Investigator Name
- Carlos Egea
- Principal Investigator Email
- carlosegeasantaolalla@gmail.com
- Contact Person Name
- Carlos Egea
- Contact Person Email
- carlosegeasantaolalla@gmail.com
- Site Name
- Instituto De Investigaciones Del Sueno S.L.
- Principal Investigator Name
- Diego García-Borreguero
- Principal Investigator Email
- dgb.investigation@iis.es
- Contact Person Name
- Diego García-Borreguero
- Contact Person Email
- dgb.investigation@iis.es
- Site Name
- Hospital Universitari De Santa Maria
- Principal Investigator Name
- Ferrán Barbé
- Principal Investigator Email
- febarbe.lleida.ics@gencat.cat
- Contact Person Name
- Ferrán Barbé
- Contact Person Email
- febarbe.lleida.ics@gencat.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Principal Investigator Name
- Irene Micaela Cano Pumarega
- Principal Investigator Email
- irene.cano@salud.madrid.org
- Contact Person Name
- Irene Micaela Cano Pumarega
- Contact Person Email
- irene.cano@salud.madrid.org
- Site Name
- Hospital Universitario De Guadalajara SESCAM
- Principal Investigator Name
- Olga Mediano San Andrés
- Principal Investigator Email
- olga.mediano@uah.es
- Contact Person Name
- Olga Mediano San Andrés
- Contact Person Email
- olga.mediano@uah.es
- Site Name
- Hospital Universitario Quironsalud Madrid
- Principal Investigator Name
- José María Echave-Susaeta
- Principal Investigator Email
- jose.echave@quironsalud.es
- Contact Person Name
- José María Echave-Susaeta
- Contact Person Email
- jose.echave@quironsalud.es
- Site Name
- Hospital Nisa Sevilla Aljarafe
- Principal Investigator Name
- Cristobal Morales Portillo
- Principal Investigator Email
- moralesPCJ@vithas.es
- Contact Person Name
- Cristobal Morales Portillo
- Contact Person Email
- moralesPCJ@vithas.es
- Site Name
- Hospital San Pedro
- Principal Investigator Name
- Alejandra Roncero
- Principal Investigator Email
- aroncerol@riojasalud.es
- Contact Person Name
- Alejandra Roncero
- Contact Person Email
- aroncerol@riojasalud.es
- Site Name
- Hospital Universitari De Santa Maria (additional listed site entries consolidated)
Poland
- Earliest CTIS Part Ii Submission Date
- 10-03-2026
- Latest Decision Or Authorization Date
- 03-04-2026
- Processing Time Days
- 24
- Number Of Sites
- 9
- Number Of Participants
- 60
Sites
- Site Name
- Centrum Badan Klinicznych Pi-House Sp. z o.o.
- Principal Investigator Name
- Monika Łukaszewicz
- Principal Investigator Email
- pihouse@pihouse.pl
- Contact Person Name
- Monika Łukaszewicz
- Contact Person Email
- pihouse@pihouse.pl
- Site Name
- 5 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Krakowie
- Department Name
- Klinika Kardiologii i Chorób Wewnętrznych
- Principal Investigator Name
- Mateusz Sidor
- Principal Investigator Email
- m.sidor@5wszk.com.pl
- Contact Person Name
- Mateusz Sidor
- Contact Person Email
- m.sidor@5wszk.com.pl
- Site Name
- Etg Warszawa Sp. z o.o.
- Principal Investigator Name
- Luiza Jonczak
- Principal Investigator Email
- warszawa@etg-network.com
- Contact Person Name
- Luiza Jonczak
- Contact Person Email
- warszawa@etg-network.com
- Site Name
- National Institute Of Tuberculosis And Lung Diseases
- Department Name
- II Klinika Chorób Płuc
- Principal Investigator Name
- Paweł Śliwiński
- Principal Investigator Email
- 2klinika@igichp.edu.pl
- Contact Person Name
- Paweł Śliwiński
- Contact Person Email
- 2klinika@igichp.edu.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Nadciśnienia Tętniczego i Diabetologii
- Principal Investigator Name
- Michał Hoffmann
- Principal Investigator Email
- michalhoffmann@gumed.edu.pl
- Contact Person Name
- Michał Hoffmann
- Contact Person Email
- michalhoffmann@gumed.edu.pl
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Klinika Chorób Wewnętrznych, Endokrynologii i Diabetologii
- Principal Investigator Name
- Edward Franek
- Principal Investigator Email
- edward.franek@cskmswia.gov.pl
- Contact Person Name
- Edward Franek
- Contact Person Email
- edward.franek@cskmswia.gov.pl
- Site Name
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
- Department Name
- Centrum Wsparcia Badań Klinicznych
- Principal Investigator Name
- Mateusz Tabin
- Principal Investigator Email
- tabin.kliniczne@gmail.com
- Contact Person Name
- Mateusz Tabin
- Contact Person Email
- tabin.kliniczne@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Pulmonologii, Alergologii i Onkologii Pulmonologicznej
- Principal Investigator Name
- Szczepan Cofta
- Principal Investigator Email
- s.cofta@gmail.com
- Contact Person Name
- Szczepan Cofta
- Contact Person Email
- s.cofta@gmail.com
- Site Name
- Gyncentrum Sp. z o.o.
- Department Name
- NZOZ GynCentrum – Oddział Warszawa
- Principal Investigator Name
- Alina Kuryłowicz
- Principal Investigator Email
- badaniakliniczne@holsaclinical.pl
- Contact Person Name
- Alina Kuryłowicz
- Contact Person Email
- badaniakliniczne@holsaclinical.pl
Sponsor
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
- WatchPAT300
- Name
- Iqvia Biotech Limited
- Responsibilities
- eCOA
- Name
- 4G Clinical B.V.
- Responsibilities
- RTSM/IWRS supplier and RTSM/IWRS helpdesk
Third parties
- {"country":"United Kingdom","full_name":"Marken Limited","duties_or_roles":"Direct to patient","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":"United States","full_name":"Roche Diabetes Care Inc.","duties_or_roles":"Blood Glucose Meter","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":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"WatchPAT300","organisation_type":"Pharmaceutical company"}
- {"country":"Austria","full_name":"The Siesta Group Schlafanalyse GmbH","duties_or_roles":"Polysomnography (PSG)","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- NNC0487-0111 B 10146
- Active Substance
- ZENAGAMTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Investigational Product Name
- NNC0487-0111 B 10143
- Active Substance
- ZENAGAMTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Investigational Product Name
- NNC0487-0111 B 10142
- Active Substance
- ZENAGAMTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Investigational Product Name
- NNC0487-0111 B 10145
- Active Substance
- ZENAGAMTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Investigational Product Name
- NNC0487-0111 B 10144
- Active Substance
- ZENAGAMTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Investigational Product Name
- NNC0487-0111 B 10141
- Active Substance
- ZENAGAMTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Investigational Product Name
- Placebo
- Modality
- Other
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