OverweightPhase 3RENEW 4NCT07745504
A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight
A Phase 3 study testing Cagrilintide in people with Overweight and Obesity, run by Novo Nordisk A/S at 36 sites in 6 countries.
Trial summary
The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. 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?
- Cagrilintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 36 sitesin 6 countries
- Study dates
- 4 Aug 2026to 6 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) greater than or equal to (>=) 30.0 kilograms per square meter (kg/m^2), or BMI >= 27.0 kg/m^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
Who cannot join
- History of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D).
- Previous dosing of marketed or non-marketed amylin-based compounds.
- Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.
Trial locations and contacts
36 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 6 countries
United States11 sites, 11 recruiting
- Recruiting
Hope Clin Res & Wellness
Conyers, Georgia, 30094
- Recruiting
PharmQuest
Greensboro, North Carolina, 27408
- Recruiting
East West Med Res Inst
Honolulu, Hawaii, 96814
- Recruiting
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260
- Recruiting
The Alliance for Multispecialty Research LLC AMR
Lexington, Kentucky, 40509
- Recruiting
Health Res of Hampton Roads
Newport News, Virginia, 23606
- Recruiting
Coastal Carolina Res Ctr
North Charleston, South Carolina, 29405
- Not yet recruiting
Walgreens - Store 11760
Oak Park, Illinois, 60302
- Recruiting
National Clin Res Inc.
Richmond, Virginia, 23294
- Recruiting
KDCILM, LLC & Accellacare US, Inc.
Wilmington, North Carolina, 28401
- Recruiting
Selma Medical Associates
Winchester, Virginia, 22601-3834
Greece6 sites, 6 recruiting
- Recruiting
General Hospital Of Athens Alexandra - Department of Endocrinology, Diabetes Center
Athens, 115 28
- Recruiting
General Hospital Of Athens G Gennimatas - Department of Endocrinology
Athens, 11527
- Recruiting
General Hospital Venizeleio-Pananeio - Diabetic Clinic
Irakleio, 71409
- Recruiting
Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department
Peristeri, 121 31
- Recruiting
Ippokratio General Hospital Of Thessaloniki - B' Internal Medicine clinic
Thessaloniki, 546 42
- Recruiting
St. Luke's Hospital S.A. - Endocrinology Department and Obesity Clinic
Thessaloniki, 552 36
Portugal6 sites, 6 recruiting
- Recruiting
ULS Do Oeste E.P.E. - Unidade Caldas da Rainha_CAMI - Unidade de Diabetes
Caldas da Rainha, 2500-176
- Recruiting
ULS Do Baixo Mondego, E.P.E. - HDFF_Serviço Cirurgia (Esp. Endocrinologia)
Figueira da Foz Municipality, 3094-001
- Recruiting
Hospital São Francisco, S.A_EECC
Leiria, 2400-110
- Recruiting
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, 1250-189
- Recruiting
CVP Hospital Cruz Vermelha_Cardiologia
Lisbon, 1549-008
- Recruiting
ULS De Gaia/Espinho_H.Santos Silva_Endocrinologia
Vila Nova de Gaia, 4434-502
Serbia5 sites, 5 recruiting
- Recruiting
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, 11000
- Recruiting
Institute for Cardiovascular Diseases of Vojvodina - Sremska Kamenica
Kamenitz, 21204
- Recruiting
Clinical Centre Nis, Endocrinology, Diabetes and Metabolism
Niš, 18000
- Recruiting
University Clinical Centre Nis, Clinic for Cardiology
Niš, 18108
- Recruiting
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, 21000
Hungary4 sites, 4 recruiting
- Recruiting
Stúdium Egészségház Kft.
Kalocsa, Bács-Kiskun county, 6300
- Recruiting
Trial Pharma Kft.
Kecskemét, 6000
- Recruiting
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405
- Recruiting
KomplexLabor Diagnosztika Kft.
Szeged, 6724
Sweden4 sites, 4 recruiting
- Recruiting
Skånes Universitets Sjukhus
Lund, 222 42
- Recruiting
Forsåker vårdcentral
Mölndal, 431 33
- Recruiting
Örebro US - Överviktsenheten
Örebro, 701 85
- Recruiting
Dalecarlia Clinical Research AB
Rättvik, 795 30
About this study
Official title: A Placebo-controlled Comparability Study to Compare Two Presentations of Cagrilintide for Weight Management in Participants With Overweight or Obesity
The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development that doctors cannot prescribe yet, but it has been tested in humans before. Participants will be in this clinical study for about 9 months.
- Conditions
- Overweight, Obesity
- Being tested
- Cagrilintide, Placebo cagrilintide, Placebo semaglutide
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagrilintideDrug
Cagrilintide will be administered subcutaneously.
Placebo cagrilintideDrug
Placebo matched to cagrilintide will be administered subcutaneously.
Placebo semaglutideDrug
Placebo matched to semaglutide will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2 | Experimental | Participants will receive cagrilintide along with placebo matched to semaglutide in device 1 and placebo matched to cagrilintide in device 2 subcutaneously (s.c) once weekly for 26 weeks. Receives: Drug: Cagrilintide; Drug: Placebo cagrilintide; Drug: Placebo semaglutide |
| Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 | Experimental | Participants will receive cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks. Receives: Drug: Cagrilintide; Drug: Placebo cagrilintide; Drug: Placebo semaglutide |
| Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 | Placebo comparator | Participants will receive placebo matched to cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks. Receives: Drug: Placebo cagrilintide; Drug: Placebo semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in body weight
Measured as percentage (%).
Measured: From baseline (week 0) to end of treatment (week 26)
Secondary outcomes (2)
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as count of events.
Measured: From baseline (week 0) to end of study (week 33)
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Measured as count of events.
Measured: From baseline (week 0) to end of study (week 33)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start4 Aug 2026
- Primary completion18 May 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745504
- Sponsor's protocol ID
- NN9833-8550
- Other IDs
- U1111-1328-5168, 2025-524249-29, 2025
- Acronym
- RENEW 4
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Sep 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Comparability Study to Compare Two Presentations of Cagrilintide for Weight Management in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07745504
- Acronym / sponsor ID
- RENEW 4 / NN9833-8550
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 18 May 2027 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development that doctors cannot prescribe yet, but it has been tested in humans before. Participants will be in this clinical study for about 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2 | Experimental | Drug: Cagrilintide, Drug: Placebo cagrilintide, Drug: Placebo semaglutideParticipants will receive cagrilintide along with placebo matched to semaglutide in device 1 and placebo matched to cagrilintide in device 2 subcutaneously (s.c) once weekly for 26 weeks. |
| Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 | Experimental | Drug: Cagrilintide, Drug: Placebo cagrilintide, Drug: Placebo semaglutideParticipants will receive cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks. |
| Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 | Placebo comparator | Drug: Placebo cagrilintide, Drug: Placebo semaglutideParticipants will receive placebo matched to cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) greater than or equal to (>=) 30.0 kilograms per square meter (kg/m^2), or BMI >= 27.0 kg/m^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
Key exclusion criteria (3 listed)
- History of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D).
- Previous dosing of marketed or non-marketed amylin-based compounds.
- Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CagrilintideCagrilintide will be administered subcutaneously. | Drug | Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2, Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 |
| Placebo cagrilintidePlacebo matched to cagrilintide will be administered subcutaneously. | Drug | Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2, Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1, Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 |
| Placebo semaglutidePlacebo matched to semaglutide will be administered subcutaneously. | Drug | Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2, Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1, Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 |
Primary outcome
Relative change in body weight
Time frame: From baseline (week 0) to end of treatment (week 26)
Measured as percentage (%).
2 secondary outcomes
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From baseline (week 0) to end of study (week 33)
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From baseline (week 0) to end of study (week 33)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisktrials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
36 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cagrilintide in people with Overweight and Obesity, run by Novo Nordisk A/S at 36 sites in 6 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 4 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Greece, Portugal, Serbia, Hungary and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. 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 26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.