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OverweightPhase 3RENEW 2NCT07220759

Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

A Phase 3 study testing Cagrilintide in people with Overweight and Obesity, run by Novo Nordisk A/S at 67 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight, Obesity, Type 2 Diabetes
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
330 participants
Where
67 sitesin 11 countries
Study dates
5 Nov 2025to 30 Jun 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.
  • Female or male (sex at birth).
  • Age 18 years or above at the time of signing the informed consent.
  • History of at least one self-reported unsuccessful dietary effort to lose body weight.(a*)
  • Body mass index (BMI) >= 27.0 kilogram per square meter (kg/m^2).
  • Diagnosed with type 2 diabetes >= 180 days before screening.(a*)
Show all 11Show fewer
  • Treatment with either lifestyle intervention(a*), or:
  • Stable treatment (same drug(s), dose and dosing frequency) for at least 90 days before screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination according to local practice.(a*)
  • For up to 30% of participants the following concomitant medication is allowed:
  • Treatment for any indication with a stable dose of glucagon-like peptide-1 (GLP-1) containing medication, stable for at least 1 year before screening (a*) and/or
  • Treatment with basal insulin minimum (0.25 units per kilogram per day (U/kg/day) or 20 units per day [U/day]) stable for at least 90 days before screening.(a*)

Who cannot join

  • Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.(a*)
  • Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomized according to inclusion criteria 7bi.(a*)
  • Previous dosing of marketed or non-marketed amylin-based compounds.(a*) (a*) - As declared by the participant, reported in the medical records or at the investigator's discretion.

Trial locations and contacts

67 sites in 11 countries.

67 sites in 11 countries

United States21 sites

  • Univ of Alabama_Birmingham

    Birmingham, Alabama, 35294

  • Holston Medical Group_Bristol

    Bristol, Tennessee, 37620

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • MediSphere Medical RC

    Evansville, Indiana, 47714

  • East West Med Res Inst

    Honolulu, Hawaii, 96814

  • Walgreens - Store 4442

    Kissimmee, Florida, 34746

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037

  • Walgreens - Store 3915

    Las Vegas, Nevada, 89146

  • Headlands Research CTR Lincoln

    Lincoln, California, 95648

  • Pacific Clinical Studies

    Los Alamitos, California, 90720

  • Chambliss Clinical Trials, LLC

    Montgomery, Alabama, 36106

  • Centricity Res New Bern Multispeciality

    New Bern, North Carolina, 28562

  • TPMG Clinical Research

    Newport News, Virginia, 23606

  • Optimal Research Sites

    Orange City, Florida, 32763

  • Center for Diab,Obes & Metab

    Pembroke Pines, Florida, 33024

  • National Clin Res Inc.

    Richmond, Virginia, 23294

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Chear Center LLC

    The Bronx, New York, 10455

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Accellacare

    Wilmington, North Carolina, 28401

Other trials in United States

Canada9 sites

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6

  • Nova Scotia Hlth Halifax

    Halifax, Nova Scotia, B3H 1V7

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8L 5G4

  • Wharton Medical Clinic Clinical Trials (Hamilton)

    Hamilton, Ontario, L8L 5G8

  • OCT Research ULC (dba Okanagan Clinical Trials)

    Kelowna, British Columbia, V1Y 1Z9

  • Milestone Research

    London, Ontario, N5W 6A2

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

  • Centricity Res Pointe-Claire

    Pointe-Claire, Quebec, H9R 4S3

  • Diex Recherche Victoriaville

    Victoriaville, Quebec, G6P 3Z8

Other trials in Canada

South Korea6 sites

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Hospital

    Seoul, 03080

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul, 06591

  • The Catholic University of Korea, Yeouido ST. Mary's Hospital

    Seoul, 07345

  • Kyunghee University Medical Center

    Seoul, 130-872

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Romania5 sites

  • CMI Dr. Pletea Noemi SRL

    Bacau, 600154

  • Diabet Med SRL

    Bucharest, 050913

  • S.C Milena Sante SRL

    Galati, 800001

  • Diabmed Dr Popescu Alexandrina SRL

    Ploieşti, Prahova, 100179

  • Clinica Korall S.R.L. Satu Mare

    Satu Mare, 440055

Other trials in Romania

United Kingdom5 sites

  • Attenborough Surgery

    Bushey, Hertfordshire, WD23 2NN

  • Oak Tree Surgery

    Liskeard, Cornwall, PL14 3XA

  • Hammersmith and Fulham Partnership Research Unit - Richford Gate Primary Care Centre

    London, W6 7HY

  • North Coast Medical Ltd

    Newquay, Cornwall, TR7 1RU

  • Brunel Medical Practice

    Torquay, Devon, TQ1 4QX

Other trials in United Kingdom

Croatia4 sites

  • Opca bolnica Karlovac

    Karlovac, 47000

  • Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology

    Krapinske Toplice, 49217

  • Poliklinika SLAVONIJA OSIJEK

    Osijek, 31000

  • Poliklinika Solmed

    Zagreb, 10000

Other trials in Croatia

Hungary4 sites

  • QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft

    Budapest, Pest County, 1036

  • Óbudai Egészségügyi Centrum

    Budapest, Pest County, 1036

  • Debreceni Egyetem

    Debrecen, Hajdú-Bihar, 4032

  • Komáromi Selye János Kórház

    Komárom, 2900

Other trials in Hungary

Switzerland4 sites

  • Universitätsspital Basel

    Basel, 4031

  • Centre hospitalier universitaire vaudois CHUV

    Lausanne, 1011

  • Kantonsspital Olten

    Olten, 4600

  • Diabetes Adipositas Zentrum Zürich

    Zollikerberg, 8125

Other trials in Switzerland

Argentina3 sites

  • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

    Buenos Aires, C1425AGC

  • Buenos Aires Mácula

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061AAE

  • CICEMO- Consultorio de Investigación Clínica EMO

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BUB

Other trials in Argentina

Czechia3 sites

  • Lékařský dům Géčko

    České Budějovice, 370 11

  • Milan Kvapil s.r.o.

    Prague, 149 00

  • EUC Klinika Praha a.s.

    Prague, 150 00

Other trials in Czechia

Slovakia3 sites

  • Nemocnica akademika L. Derera, UNB

    Bratislava, 831 01

  • DIAB s.r.o.

    Rožňava, 04801

  • IRIDIA s.r.o.

    Vrútky, 038 61

Other trials in Slovakia

About this study

Official title: Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity and Type 2 Diabetes

This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.

Being tested
Cagrilintide, Placebo (matched to Cagrilintide)
Medical subject headings
Overweight, Obesity, Diabetes Mellitus, Type 2

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 with a pen-injector as an adjunt to lifestyle intervention counselling.

  • Placebo (matched to Cagrilintide)Drug

    Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Study groups in NCT07220759
Study groupRoleWhat they receive
CagrilintideExperimentalParticipants will receive cagrilintide subcutaneously once weekly for 64 weeks.
Receives: Drug: Cagrilintide
PlaceboPlacebo comparatorParticipants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.
Receives: Drug: Placebo (matched to Cagrilintide)

What is being measured

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

  1. Relative change in body weight

    Measured as percentage (%) of body weight.

    Measured: From baseline (week 0) to end of treatment (week 64)

Secondary outcomes (28)

  1. Number of participants with achievement of >= 10% body weight reduction (yes/no)

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 64)

  2. Number of participants with achievement of >= 15% body weight reduction (yes/no)

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 64)

  3. Change in waist circumference

    Measured as centimeter (cm).

    Measured: From baseline (week 0) to end of treatment (week 64)

  4. Ratio to baseline in lipids: triglycerides

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 64)

  5. Ratio to baseline in high sensitivity C-reactive protein (hsCRP)

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 64)

  6. Change in glycated haemoglobin (HbA1c)

    Measured as percentage of HbA1c.

    Measured: From baseline (week 0) to end of treatment (week 64)

  7. Change in impact of weight on quality of life-lite clinical trials version (IWQOL-Lite-CT) physical function score

    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.

    Measured: From baseline (week 0) to end of treatment (week 64)

  8. Change in systolic blood pressure (SBP)

    Measured as millimeter of mercury (mmHg).

    Measured: From baseline (week 0) to end of treatment (week 64)

  9. Change in body weight

    Measured as kilogram (kg).

    Measured: From baseline (week 0) to end of treatment (week 64)

  10. Number of participants with achievement of >= 5% body weight reduction (yes/no)

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 64)

  11. Change in SF-36v2® health survey acute (SF-36v2® acute) physical component summary score

    Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The physical component summary score ranges from 6.1 to 79.7.

    Measured: From baseline (week 0) to end of treatment (week 64)

  12. Change in SF-36v2® mental component summary score

    Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The mental component summary score ranges from -3.8 to 78.7.

    Measured: From baseline (week 0) to end of treatment (week 64)

  13. Change in IWQOL-Lite-CT total score

    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The total score ranges from 0-100.

    Measured: From baseline (week 0) to end of treatment (week 64)

  14. Number of participants with achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT physical function score

    Measured as count of participants. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.

    Measured: From baseline (week 0) to end of treatment (week 64)

  15. Change in diastolic blood pressure (DBP)

    Measured as mmHg.

    Measured: From baseline (week 0) to end of treatment (week 64)

  16. Ratio to baseline in lipids: total cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 64)

  17. Ratio to baseline in lipids: high-density lipoprotein (HDL) cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 64)

  18. Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 64)

  19. Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 64)

  20. Ratio to baseline in lipids: non-HDL cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 64)

  21. Ratio to baseline in lipids: free fatty acids

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 64)

  22. Change in fasting plasma glucose (FPG) in millimole per liter (mmol/L)

    Measured as mmol/L.

    Measured: From baseline (week 0) to end of treatment (week 64)

  23. Change in FPG in milligram per deciliter (mg/dL)

    Measured as mg/dL.

    Measured: From baseline (week 0) to end of treatment (week 64)

  24. Ratio to baseline in fasting serum insulin

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 64)

  25. Number of treatment emergent adverse events

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (week 71)

  26. Number of treatment emergent serious adverse events (TESAEs)

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (week 71)

  27. Number of clinically significant hypoglycaemic episodes (level 2):<3.0 mmol/L [54 mg/dL], confirmed by blood glucose meter

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (week 71)

  28. Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (week 71)

Timeline

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

  1. First posted24 Oct 2025
  2. Study start5 Nov 2025
  3. Primary completion12 May 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

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
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07220759
Sponsor's protocol ID
NN9833-8243
Other IDs
U1111-1314-9328, 2024-519531-41
Acronym
RENEW 2
Status last verified
Oct 2026
First submitted
23 Oct 2025
Last updated
7 Oct 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 novonordisk-trials.com

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 67 sites in 11 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 11 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Canada, South Korea, Romania, United Kingdom and 6 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?

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?

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 64)). 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 NCT07220759.

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 7 Oct 2026.

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