Type 2 DiabetesPhase 3REIMAGINE 1NCT06323174
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise
A Phase 3 study testing Cagrilintide and Semaglutide in people with Type 2 Diabetes, run by Novo Nordisk A/S at 50 sites in 7 countries.
Trial summary
This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Cagrilintide and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 50 sitesin 7 countries
- Study dates
- 19 Mar 2024to 22 Dec 2025
- 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
- Age 18 years or above at the time of signing the informed consent
- Diagnosed with type 2 diabetes >=30 days before screening
- HbA1c 7.0-9.5 percent (53-80 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening
- Body mass index (BMI) >=23 kilograms per square meter (kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method
- Renal impairment with estimated Glomerular Filtration Rate less than 30 milliliter per minute per 1.73 square meter (ml/min/1.73 m^2) as determined by central laboratory at screening
- Treatment with any medication for the indication of diabetes or obesity within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
- History of use of any injectable therapy for diabetes or obesity. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Trial locations and contacts
50 sites in 7 countries.
50 sites in 7 countries
United States21 sites
Amarillo Medical Specialists
Amarillo, Texas, 79124
Elligo Clin Res Centre
Austin, Texas, 78704
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Headlands Research Brownsville
Brownsville, Texas, 78526
Velocity Clinical Res-Dallas
Dallas, Texas, 75230
Encore Medical Research LLC
Hollywood, Florida, 33024
Nat Res Inst Huntington Park
Huntington Park, California, 90255
Holston Medical Group
Kingsport, Tennessee, 37660
TPMG Clinical Research
Newport News, Virginia, 23606
Alliance for Multispec Res
Newton, Kansas, 67114
Valley Clinical Trials, Inc.
Northridge, California, 91325
Headlands Research Orlando
Orlando, Florida, 32819
Summit Research Network Oregon Inc.
Portland, Oregon, 97210
Northeast Clinical Research of San Antonio
San Antonio, Texas, 78233
Southern California Dermatology
Santa Ana, California, 92701
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Sugar Lakes Family Practice PA
Sugar Land, Texas, 77479
Arcturus HC PLC Troy Med Res
Troy, Michigan, 48098
Valley Diab. & Endo Comp Ctr
Weslaco, Texas, 78596
Southgate Medical Group, LLP
West Seneca, New York, 14224
Encore Medical Research of Weston
Weston, Florida, 33331
Poland7 sites
Osteo-Medic s.c. A. Racewicz, J. Supronik
Bialystok, 15-351
Renew Clinic Sp. z o.o.
Bialystok, 15-797
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, 90-338
Centrum Medyczne Medyk Sp. z o.o.
Rzeszów, Podkarpackie Voivodeship, 35-055
NBR Polska Tomasz Klodawski
Warsaw, 00-710
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, 02-507
Velocity Nova Sp. z o.o.
Zamość, 22-400
China5 sites
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, 100853
Jinan Central Hospital
Ji'Nan, Shandong, 250000
Jinan Central Hospital
Jinan, Shandong, 250000
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, 210011
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, 212001
Saudi Arabia5 sites
King Abdulaziz Hospital-Al Ahsa-National Guard
Al Ahsa, 36428
National Guard Hospital - Jeddah
Jeddah, 21423
King Fahad Medical City
Riyadh, 11525
King Khaled University Hospital,King Saud Univ. Med. City
Riyadh, 12372
King Salman Bin Abdulaziz Hospital
Riyadh, 12769
Hungary4 sites
Szent Margit Rendelőintézet Nonprofit Kft.
Budapest, 1032
PVN Kutató Kft.
Budapest, 1102
Belinus Bt.
Debrecen, Hajdú-Bihar, 4025
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405
Italy4 sites
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
Policlinico Mater Domini Università di Catanzaro
Catanzaro, 88100
IRCCS Ospedale San Raffaele Milano
Milan, 20132
Azienda Ospealiero Universitaria Policlinico Umberto I
Roma, 00161
Serbia4 sites
CHC Zvezdara, Clinical department for endocrinology
Belgrade, 11000
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11080
Clinical Hospital Centre Zemun
Belgrade, 11080
Policlinic for diabetes
Zaječar, 19000
About this study
Official title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Diet and Exercise
This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.
- Conditions
- Type 2 Diabetes
- Being tested
- Cagrilintide, Semaglutide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagrilintideDrug
Participants will receive once-weekly cagrilintide subcutaneously.
SemaglutideDrug
Participants will receive once-weekly semaglutide subcutaneously.
PlaceboDrug
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| CagriSema Dose 2 | Active comparator | Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 24 weeks. Receives: Drug: Cagrilintide; Drug: Semaglutide |
| Placebo Dose 2 | Placebo comparator | Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 2 for 40 weeks. Receives: Drug: Placebo |
| Cagrisema Dose 1 | Active comparator | Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks. Receives: Drug: Cagrilintide; Drug: Semaglutide |
| Placebo Dose 1 | Placebo comparator | Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 1 for 40 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated haemoglobin (HbA1c)
Measured as percentage (%)-points.
Measured: From baseline (week 0) to end of treatment (week 40)
Secondary outcomes (30)
Relative change in body weight
Measured in %.
Measured: From baseline (week 0) to end of treatment (week 40)
Number of participants who achieve greater than or equal to (>=) 10% body weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to end of treatment (week 40)
Number of participants who achieve >=15% body weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to end of treatment (week 40)
Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])
Measured as count of participants.
Measured: At end of treatment (week 40)
Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol)
Measured as count of participants.
Measured: At end of treatment (week 40)
Change in Fasting Plasma Glucose (FPG)
Measured in millimoles per liter (mmol/L).
Measured: From baseline (week 0) to end of treatment (week 40)
Number of participants who achieve >=5% body weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to end of treatment (week 40)
Number of participants who achieve >=20% body weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to end of treatment (week 40)
Change in waist circumference
Measured in centimeters (cm).
Measured: From baseline (week 0) to end of treatment (week 40)
Change in systolic blood pressure (SBP)
Measured in millimeters of mercury (mmHg).
Measured: From baseline (week 0) to end of treatment (week 40)
Change in diastolic blood pressure (DBP)
Measured in mmHg.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in high sensitivity C-reactive protein (hsCRP)
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: Total cholesterol
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: Triglycerides
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: Free fatty acids
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: Non-HDL cholesterol
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication)
Measured as count of participants.
Measured: At end of study (week 52)
Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo)
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score
Measured as score points. 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 vitality score range is from 25.6 to 69.1.
Measured: From baseline (week 0) to end of treatment (week 40)
Change in SF-36v2 score: Physical Component Summary score
Measured as score points. SF-36v2 Acute measures 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 score range for physical component summary is 6.1 to 79.7.
Measured: From baseline (week 0) to end of treatment (week 40)
Change in SF-36v2 score: Mental Component Summary score
Measured as score points. SF-36v2 Acute measures 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 score range for mental component summary score is -3.8 to 78.7.
Measured: From baseline (week 0) to end of treatment (week 40)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score
Measured as score points. DTSQs measures treatment satisfaction and diabetes-specific quality of life. The measure consists of 8 items yielding 1 global score and 2 single item scores. Higher scores on the global score indicate greater satisfaction with treatment. Lower scores on the single-item scores indicate BG levels closer to the ideal, while higher scores indicate problems. Single-item scores (score range): Perceived frequency of hyperglycaemia (0-6), Perceived frequency of hypoglycaemia (0-6). Global score (score range): Total Treatment Satisfaction (0-36).
Measured: From baseline (week 0) to end of treatment (week 40)
Change in leptin
Measured in nanograms per milliliter (ng/mL).
Measured: From baseline (week 0) to end of treatment (week 40)
Change in soluble leptin receptor
Measured in ng/mL.
Measured: From baseline (week 0) to end of treatment (week 40)
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as count of events.
Measured: From baseline (week 0) to end of treatment +7 weeks (week 47)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter
Measured as count of episodes.
Measured: From baseline (week 0) to end of treatment +7 weeks (week 47)
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 episodes.
Measured: From baseline (week 0) to end of treatment + 7 weeks (week 47)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start19 Mar 2024
- Primary completion1 Oct 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- 189 participants (actual)
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
- NCT06323174
- Sponsor's protocol ID
- NN9388-4895
- Other IDs
- 2022-502677-42, U1111-1283-0404
- Acronym
- REIMAGINE 1
- Status last verified
- Sep 2026
- First submitted
- 15 Mar 2024
- Last updated
- 30 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 novonordisk-trials.com.
Publications
Aroda VR, Buzzetti R, Dalskov SM, Jain AB, Larsen JH, Mathieu C, Pratley RE, Videmark A, Watt T, Buse JB. Efficacy and safety of once-weekly cagrilintide-semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): a randomised, double-blind, placebo-controlled, phase 3a study. Lancet Diabetes Endocrinol. 2026 Aug;14(8):649-661. doi: 10.1016/S2213-8587(26)00126-9. Epub 2026 Jun 7.
PubMed 42251860
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Diet and Exercise
- ClinicalTrials.gov ID
- NCT06323174
- Acronym / sponsor ID
- REIMAGINE 1 / NN9388-4895
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 21 Mar 2024 (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.
This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CagriSema Dose 2 | Active comparator | Drug: Cagrilintide, Drug: SemaglutideParticipants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 24 weeks. |
| Placebo Dose 2 | Placebo comparator | Drug: PlaceboParticipants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 2 for 40 weeks. |
| Cagrisema Dose 1 | Active comparator | Drug: Cagrilintide, Drug: SemaglutideParticipants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks. |
| Placebo Dose 1 | Placebo comparator | Drug: PlaceboParticipants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 1 for 40 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- Age 18 years or above at the time of signing the informed consent
- Diagnosed with type 2 diabetes >=30 days before screening
- HbA1c 7.0-9.5 percent (53-80 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening
- Body mass index (BMI) >=23 kilograms per square meter (kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening
Key exclusion criteria (5 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method
- Renal impairment with estimated Glomerular Filtration Rate less than 30 milliliter per minute per 1.73 square meter (ml/min/1.73 m^2) as determined by central laboratory at screening
- Treatment with any medication for the indication of diabetes or obesity within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
- History of use of any injectable therapy for diabetes or obesity. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
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 |
|---|---|---|
| CagrilintideParticipants will receive once-weekly cagrilintide subcutaneously. | Drug | CagriSema Dose 2, Cagrisema Dose 1 |
| SemaglutideParticipants will receive once-weekly semaglutide subcutaneously. | Drug | CagriSema Dose 2, Cagrisema Dose 1 |
| PlaceboParticipants will receive placebo matched to cagrilintide and semaglutide subcutaneously. | Drug | Placebo Dose 1, Placebo Dose 2 |
Primary outcome
Change in glycated haemoglobin (HbA1c)
Time frame: From baseline (week 0) to end of treatment (week 40)
Measured as percentage (%)-points.
30 secondary outcomes
Relative change in body weight
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of participants who achieve greater than or equal to (>=) 10% body weight reduction
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of participants who achieve >=15% body weight reduction
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])
Time frame: At end of treatment (week 40)
Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol)
Time frame: At end of treatment (week 40)
Change in Fasting Plasma Glucose (FPG)
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of participants who achieve >=5% body weight reduction
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of participants who achieve >=20% body weight reduction
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in waist circumference
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in systolic blood pressure (SBP)
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in diastolic blood pressure (DBP)
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in high sensitivity C-reactive protein (hsCRP)
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: Total cholesterol
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: Triglycerides
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: Free fatty acids
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to baseline in lipids: Non-HDL cholesterol
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication)
Time frame: At end of study (week 52)
Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo)
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in SF-36v2 score: Physical Component Summary score
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in SF-36v2 score: Mental Component Summary score
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in leptin
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in soluble leptin receptor
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From baseline (week 0) to end of treatment +7 weeks (week 47)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter
Time frame: From baseline (week 0) to end of treatment +7 weeks (week 47)
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
Time frame: From baseline (week 0) to end of treatment + 7 weeks (week 47)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Derived from this study: PubMed 42251860Aroda VR, Buzzetti R, Dalskov SM, Jain AB, Larsen JH, Mathieu C, Pratley RE, Videmark A, Watt T, Buse JB. Efficacy and safety of once-weekly cagrilintide-semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): a randomised, double-blind, placebo-controlled, phase 3a study. Lancet Diabetes Endocrinol. 2026 Aug;14(8):649-661. doi: 10.1016/S2213-8587(26)00126-9. Epub 2026 Jun 7.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
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. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
50 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cagrilintide and Semaglutide in people with Type 2 Diabetes, run by Novo Nordisk A/S at 50 sites in 7 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 30 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 50 sites in United States, Poland, China, Saudi Arabia, Hungary and 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in glycated haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of treatment (week 40)). 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 NCT06323174, which also lists 1 linked publication.
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 30 Sep 2026.