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OverweightPhase 3NCT07357766

A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight

A Phase 3 study testing Cagrisema in people with Overweight and Obesity, run by Novo Nordisk A/S at 116 sites in 14 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight, Obesity
What is being tested?
Cagrisema
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
116 sitesin 14 countries
Study dates
22 Jun 2026to 17 Jan 2028
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female (sex at birth)
  • Age 18 years or above at the time of signing the informing consent.
  • Body Mass Index (BMI) is greater than or equal to (>= ) 30.0 kilograms per square metre (kg/m^2) or BMI >= 27.0 kg/m^2 with the presence of at least one obesity-related complication including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

Who cannot join

  • Glycosylated haemoglobin (HbA1c) >= 6.5 % (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
  • History of type 1 or type 2 diabetes.
  • Previous exposure to CagriSema in a clinical study.

Trial locations and contacts

116 sites in 14 countries.

116 sites in 14 countries

United States26 sites

  • Elligo Clin Res Centre

    Austin, Texas, 78704

  • Uni of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Anointed Nephrology & HTN, LLC

    Brookhaven, Mississippi, 39601

  • PGM Research of Christie Clinic

    Champaign, Illinois, 61822

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9302

  • Tribe Clinical Research LLC

    Greer, South Carolina, 29650

  • Forefront Med Res Inst PLLC

    Harlingen, Texas, 78550

  • Advanced Investigative Medicine, Inc.

    Hawthorne, California, 90250

  • NextPhase Research

    Hollywood, Florida, 33024

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • Palm Research Center Inc.

    Las Vegas, Nevada, 89128

  • Palm Research Center Inc.

    Las Vegas, Nevada, 89148

  • Walker Family Care

    Little River, South Carolina, 29566

  • Oceane 7 Medical & Research Center, Inc.

    Miami, Florida, 33144

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • TPMG Clinical Research

    Newport News, Virginia, 23606

  • Alliance for Multispecialty Research

    Norman, Oklahoma, 73069

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502

  • Cahaba Research

    Pelham, Alabama, 35124

  • Southern Cal Clinical Research

    Santa Ana, California, 92701

  • EBGS Clinical Research Center, LLC

    Snellville, Georgia, 30078

  • Encompass Clinical Research_Spring Valley

    Spring Valley, California, 91978

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • Arcturus HC PLC Troy Med Res

    Troy, Michigan, 48098

  • Rophe Adult & Pediatric Medicine

    Union City, Georgia, 30291

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708

Other trials in United States

Bulgaria13 sites

  • IPSMC - Dr. Nikolay Kostadinov EOOD

    Burgas, 8000

  • Medical Center Viva Feniks OOD

    Dobrich, 9300

  • IPSOMC Dr. Miglena Rizova Ltd.

    Kyustendil, 2500

  • UMHAT Pulmed OOD - Plovdiv, Department of Endocrinology

    Plovdiv, 4002

  • UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Endocrinology

    Plovdiv, 4002

  • MHAT Sveta Karidad EAD

    Plovdiv, 4004

  • DCC Iztok EOOD

    Plovdiv, 4006

  • Medical Centre Razgrad OOD

    Razgrad, 7200

  • DCC VII - Sofia EOOD, Endocrinology

    Sofia, 1233

  • Diagnostic-Consultative Anti-Aging and Rejuvenation Center Hill Clinic EAD

    Sofia, 1618

  • Medical Center Medical Plus EOOD

    Varna, 9000

  • DCC Mladost - M Varna OOD

    Varna, 9009

  • AIPSMC Dr. Artin Magardichyan EOOD

    Varna, 9020

Other trials in Bulgaria

Malaysia11 sites

  • Hospital Canselor Tuanku Muhriz UKM

    Cheras, Kuala Lumpur, 56000

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10990

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan, 15586

  • Klinik Kesihatan Kuala Kedah

    Kuala Kedah, 05460

  • University Malaya Medical Centre

    Lembah Pantai, Kuala Lumpur, 59100

  • Hospital Melaka

    Malacca, 75400

  • Hospital Miri

    Miri, Sarawak, 98000

  • Klinik Kesihatan Kuang

    Rawang, Selangor, 48050

  • Hospital Queen Elizabeth II

    Sabak Bernam, 88300

  • Hospital Seri Manjung

    Seri Manjung, Perak, 32040

  • University Technology MARA (UiTM) - Sg Buloh

    Sungai Buloh, Selangor, 47000

Other trials in Malaysia

Poland11 sites

  • Gabinet Leczenia Otylosci i Chorob Dietozaleznych

    Bialystok, 15-281

  • Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.

    Bydgoszcz, 85-231

  • Niepubliczny Zakład Opieki Zdrowotnej BIF-MED S.C. Arkadiusz Wawiernia, Mariola Roykiewicz, Rafał Roykiewicz

    Bytom, 41-902

  • NZOZ Mediart Centrum Zdrowia Matarnia

    Gdansk, 80-298

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, 80-382

  • ID Clinic Arkadiusz Pisula

    Mysłowice, 41-400

  • Clinical Best Solutions Sp. z o.o., Sp. k

    Warsaw, 00-710

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, 02-672

  • Kardio Life - Tomasz Borkowski

    Włocławek, 87-800

  • Velocity Nova Sp. z o.o.

    Zamość, 22-400

  • Prywatna Praktyka Lekarska Anna Chudoba

    Żyrardów, 96-300

Other trials in Poland

Greece7 sites

  • 251 Air Force General Hospital - Department of Endocrinology & Diabetes

    Athens, 11525

  • General Hospital Of Athens G Gennimatas - Department of Endocrinology

    Athens, 11527

  • Laiko General Hospital Of Athens - A' Propaedeutic Clinic of Internal Medicine-Diabetes Centre

    Athens, 11527

  • Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit

    Marousi, 15125

  • Athens Medical Center S.A. (Iatriko P. Falirou) - Diabetes and Clinical Research Center

    Palaió Fáliro, 17562

  • General Hospital Of Thessaloniki G Gennimatas - Internal Medicine Clinic

    Thessaloniki, 546 35

  • Thermi Clinic S.A. - Diabetes and Internal Medicine Department

    Thessaloniki, 57001

Other trials in Greece

Romania7 sites

  • Thera Card S.R.L

    Brasov, 500102

  • Kilostop Junior SRL

    Bucharest, 010073

  • SC Diamed Obesity SRL

    Galati, 800291

  • Arcadia Policlinic SRL

    Iași, 700620

  • Spital Judetean De Urgenta Satu Mare

    Satu Mare, 440055

  • SC Gensan SRL, Policlinica ASTRA

    Sibiu, 550371

  • Spitalul Clinic Judetean De Urgenta Targu Mures

    Târgu Mureş, 540136

Other trials in Romania

South Africa7 sites

  • Dr Vawda's site

    Durban, KwaZulu-Natal, 4091

  • Dr T Padayachee

    Durban, KwaZulu-Natal, 4170

  • Dr Moosa's Rooms

    Gauteng, Lenasia, 1827

  • Soweto Clinical Trial Centre

    Johannesburg, Gauteng, 1818

  • Ezintsha Research Centre

    Johannesburg, Gauteng, 2193

  • Clinical Research Institute of South Africa

    KwaDukuza, KwaZulu-Natal, 4449

  • Dr A Jacovides and Partners Inc

    Midrand, Gauteng, 1685

Other trials in South Africa

Hungary6 sites

  • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, 1089

  • Belinus Bt.

    Debrecen, Hajdú-Bihar, 4025

  • Debreceni Egyetem

    Debrecen, Hajdú-Bihar, 4032

  • Borbánya Praxis E.Ü. Kft.

    Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405

  • Arina Trial Research Kft.

    Orosháza, Bekes County, 5900

  • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

    Szeged, Csongrád-Csanád, 6725

Other trials in Hungary

Portugal6 sites

  • ULS De Braga, E.P.E. - Hospital de Braga_Centro Clínico Académico

    Braga, 4710-243

  • ULS Do Alto Ave, E.P.E - HSOG_Centro de Investigação Clínica

    Guimarães, 4835-044

  • Hospital São Francisco, S.A_EECC

    Leiria, 2400-110

  • APDP - Associação Protectora dos Diabéticos de Portugal

    Lisbon, 1250-189

  • Affidea Montijo - UCardio

    Montijo, 2870-100

  • Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda

    Ponte de Lima, 4990-029

Other trials in Portugal

Thailand6 sites

  • Ramathibodi Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai

    Chiang Mai, 50200

  • RIHES-CMU_Research Institute for Health Sciences

    Chiang Mai, 50200

  • Hat Yai hospital

    Hat Yai, Changwat Songkhla, 90110

  • Thammasat Hospital_CRC

    Pathum Thani, 12120

Other trials in Thailand

Slovakia5 sites

  • MED-CENTRUM, s.r.o.

    Martin, 036 01

  • KARDIOMED NZ, s.r.o.

    Nové Zámky, 940 01

  • SVAJDLEROVA, s.r.o.

    Prešov, 080 01

  • ENRIN, s.r.o.

    Rimavská Sobota, 979 01

  • DIAB s.r.o.

    Rožňava, 04801

Other trials in Slovakia

Switzerland4 sites

  • Luzerner Kantonsspital

    Lucerne, 6004

  • Kantonsspital Olten

    Olten, 4600

  • Stoffwechselzentrum St. Gallen

    Sankt Gallen, 9016

  • Diabetes Adipositas Zentrum Zürich

    Zollikerberg, 8125

Other trials in Switzerland

Taiwan4 sites

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital

    Chiayi City, 600

  • Kuang Tien General Hospital

    Taichung, 433

  • Chi Mei Medical Center

    Tainan, 710

  • Taipei Municipal Wan Fang Hospital_Division of Endocrinology & Metabolism

    Taipei, 116

Other trials in Taiwan

Denmark3 sites

  • Sanos Clinic - Gandrup

    Gandrup, 9362

  • Sanos Clinic - Vejle

    Vejle, Region Syddanmark, 7100

  • Regionshospitalet Viborg - Karkirurgisk Afsnit

    Viborg, 8800

Other trials in Denmark

About this study

Official title: A Placebo-controlled Comparability Study to Compare Two Presentations of CagriSema in Participants With Overweight or Obesity

This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance using a computer program, so neither participants nor study staff will know which treatment is given. The study will last for about one year.

Conditions
Overweight, Obesity
Being tested
Cagrisema, Placebo CagriSema
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CagrisemaDrug

    Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously using device 1 or device 2.

  • Placebo CagriSemaDrug

    Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.

Study groups in NCT07357766
Study groupRoleWhat they receive
CagriSema B in device 2 + Placebo in device 1ExperimentalParticipants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.
Receives: Drug: Cagrisema
CagriSema in device 1 + Placebo in device 2ExperimentalParticipants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.
Receives: Drug: Cagrisema
Placebo in device 1 + Placebo in device 2Placebo comparatorParticipants will receive placebo matched to Cagrisema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly for up to 44 weeks.
Receives: Drug: Placebo CagriSema

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative change in body weight

    Measured in percentage (%).

    Measured: From baseline (week 0) to end of treatment (week 44)

Secondary outcomes (2)

  1. Number of TEAEs (treatment emergent adverse events)

    Measured in count of events.

    Measured: From baseline (week 0) to end of study (week 51)

  2. Number of TESAEs (Treatment emergent serious adverse events)

    Measured in count of events.

    Measured: From baseline (week 0) to end of study (week 51)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start22 Jun 2026 (estimated)
  3. Primary completion29 Nov 2027 (estimated)
  4. Study completion17 Jan 2028 (estimated)

Why it stopped: The study is withdrawn due to strategic reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07357766
Sponsor's protocol ID
NN9838-8166
Other IDs
U1111-1317-0133, 2024-520448-41
Status last verified
Jul 2026
First submitted
21 Jan 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cagrisema in people with Overweight and Obesity, run by Novo Nordisk A/S at 116 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Bulgaria, Malaysia, Poland, Greece and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 44)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07357766.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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