ObesityPhase 3NCT06780449
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
A Phase 3 study testing Cagrilintide and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 36 sites in 6 countries.
Trial summary
This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- 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
- 400 participants
- Where
- 36 sitesin 6 countries
- Study dates
- 10 Feb 2025to 31 Oct 2028
- 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
- Male or female.
- Age above or equal to 18 years at the time of signing informed consent.
- Body mass index (BMI) greater than or equal to (>=) 35.0 kilograms per meter square (kg/m^2).
Who cannot join
- Glycated haemoglobin (HbA1c) >= 6.5 percent (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes.
Trial locations and contacts
36 sites in 6 countries.
36 sites in 6 countries
United States10 sites
Washington Cntr Weight Mgmt
Arlington, Virginia, 22206
Holston Medical Group_Bristol
Bristol, Tennessee, 37620
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303
Valley Clinical Trials
Covina, California, 91723
North Texas Endocrine Center
Dallas, Texas, 75231
East West Medical Research Institute_Honolulu
Honolulu, Hawaii, 96814
L-MARC Research Center
Louisville, Kentucky, 40213
Yale University School Of Medicine
New Haven, Connecticut, 06519
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
United Kingdom7 sites
Southmead Hospital
Bristol, BS10 5NB
Addenbrooke's Hospital_Cambridge
Cambridge, CB2 0QQ
University Hospital Coventry - WISDEM Centre
Coventry, CV2 2DX
Aintree University Hospital
Liverpool, L9 7AL
Royal London Hospital - Blizard Institute
London, E1 2AJ
Joint Clinical Research Facility - Swansea
Swansea, SA2 8PP
Musgrove Park Hospital
Taunton, TA1 5DA
Portugal6 sites
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, 1250-189
CUF Descobertas
Lisbon, 1998-018
Hospital Cuf Descobertas S.A.
Lisbon, 1998-018
Unidade Local de Saude de Sao Joao E.P.E
Porto, 4200-319
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
Senhora Da Hora, Matosinhos, Matosinhos, 4464-513
Hospital Luz Arrabida, S.A.
Vila Nova de Gaia, 4400-346
Denmark5 sites
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus, 8200
Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
Esbjerg, 6700
Gentofte Hospital - Center for Klinisk Metabolisk Forskning
Hellerup, 2900
Hvidovre Hospital Endokrinologisk forsknings afsnit 159
Hvidovre, 2650
Sjællands Universitetshospital, Køge - Medicinsk Afdeling
Køge, 4600
Belgium4 sites
Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
Brussels, 1200
UZA - UZ Antwerpen - Department of Endocrinology
Edegem, 2650
UZ Leuven - Endocrinology
Leuven, 3000
CHU Helora - Hôpital de Mons - Site Constantinople
Mons, 7000
Canada4 sites
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, L8L 5G4
Alpha Recherche Clinique - Lebourgneuf
Québec, G2J 0C4
Dr. M.B. Jones Inc
Victoria, British Columbia, V8V 4A1
About this study
Official title: Long-term Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Placebo in Participants With Obesity
This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.
- Conditions
- Obesity
- Being tested
- Cagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagrilintideDrug
Participants will receive cagrilintide subcutaneously.
SemaglutideDrug
Participants will receive semaglutide subcutaneously.
Placebo cagrilintideDrug
Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo semaglutideDrug
Participants will receive placebo matched to semaglutide subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| CagriSema | Experimental | Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) after a dose escalation period of 16 weeks during the maintenance period for 88 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for one year. Receives: Drug: Cagrilintide; Drug: Semaglutide |
| Placebo | Placebo comparator | Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once weekly for 104 weeks. Participants randomised to this arm will be included in the extension phase for one year. 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 in percentage (%).
Measured: From baseline (week 0) to week 104
Secondary outcomes (59)
Number of participants who achieve greater than or equal to (>=) 20 percent body weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to week 104
Number of participants who achieve >= 25 percent body weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to week 104
Number of participants who achieve >= 30 percent body weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to week 104
Change in waist circumference
Measured in centimeter (cm).
Measured: From baseline (week 0) to week 104
Change in waist to height ratio
Measured as ratio.
Measured: From baseline (week 0) to week 104
Change in Systolic Blood Pressure (SBP)
Measured in millimeter of mercury (mmHg).
Measured: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Total Cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Triglycerides
Measured as ratio.
Measured: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Free fatty acids
Measured as ratio.
Measured: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Non-HDL cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 104
Change in Body Mass Index (BMI)
Measured in kilograms per meter square (kg/m^2).
Measured: From baseline (week 0) to week 104
Number of participants who achieve BMI less than 30 kg/m^2
Measured as count of participants.
Measured: At week 104
Change in Glycated Haemoglobin (HbA1c) (percentage points)
Measured in percentage points.
Measured: From baseline (week 0) to week 104
Change in HbA1c (millimoles per mole [mmol/mol])
Measured in mmol/mol.
Measured: From baseline (week 0) to week 104
Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])
Measured as mmol/L.
Measured: From baseline (week 0) to week 104
Change in FPG (milligrams per deciliter [mg/dL])
Measured as mg/dL.
Measured: From baseline (week 0) to week 104
Number of participants who achieve HbA1c less than (<) 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline
Measured as count of participants.
Measured: From baseline (week 0) to week 104
Number of participants who achieve HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline
Measured as count of participants.
Measured: From baseline (week 0) to week 104
Time to HbA1c < 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline
Measured in days.
Measured: From baseline (week 0) to week 104
Time to HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline
Measured in days.
Measured: From baseline (week 0) to week 104
Number of participants who develop HbA1c >= 5.7 percent or FPG greater than (>) 100 mg/dL with normoglycemia at baseline
Measured as count of participants.
Measured: From baseline (week 0) to week 104
Number of participants who develop type 2 diabetes (T2D) as per American Diabetes Association (ADA) guideline
Measured as count of participants.
Measured: From baseline (week 0) to week 104
Time to T2D diagnosis as per ADA guideline
Measured in days.
Measured: From baseline (week 0) to week 104
Change in American College of Cardiology/American Heart Association (ACC/AHA) 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk score
Measured in percentage of risk. American College of Cardiology/American Heart Association (ACC/AHA) risk estimator calculates 10 year risk of atherosclerotic cardiovascular disease (ASCVD) using a formula which includes age, sex, race, total cholesterol, HDL cholesterol, systolic blood pressure, blood pressure medication use, diabetes status, smoking status; minimum score 0, maximum score 100 where higher score indicates higher risk of 10-year risk of atherosclerotic cardiovascular disease (ASCVD).
Measured: From baseline (week 0) to week 104
Number of participants who improve in >= 1 pre-existing cardiometabolic obesity related com-plication (ORC) (hypertension, prediabetes, or dyslipidaemia)
Measured as count of participants.
Measured: From baseline (week 0) to week 104
Ratio to baseline in C-reactive protein (CRP)
Measured as ratio.
Measured: From baseline (week 0) to week 104
Change in total fat mass by dual energy X-ray absorption (DXA) absolute to total body mass (kilogram [kg])
Measured in kg.
Measured: From baseline (week 0) to week 104
Change in total fat mass by DXA relative to total body mass (kg)
Measured in kg.
Measured: From baseline (week 0) to week 104
Change in total fat mass by DXA absolute to total body mass (percentage points)
Measured in percentage points.
Measured: From baseline (week 0) to week 104
Change in total fat mass by DXA relative to total body mass (percentage points)
Measured in percentage points.
Measured: From baseline (week 0) to week 104
Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage)
Measured in percentage.
Measured: From baseline (week 0) to week 104
Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage)
Measured in percentage.
Measured: From baseline (week 0) to week 104
Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage points)
Measured in percentage points.
Measured: From baseline (week 0) to week 104
Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage points)
Measured in percentage points.
Measured: From baseline (week 0) to week 104
Change in lean body mass by DXA absolute to total body mass (kg)
Measured in kg.
Measured: From baseline (week 0) to week 104
Change in lean body mass by DXA relative to total body mass (kg)
Measured in kg.
Measured: From baseline (week 0) to week 104
Change in lean body mass by DXA absolute to total body mass (percentage points)
Measured in percentage points.
Measured: From baseline (week 0) to week 104
Change in lean body mass by DXA relative to total body mass (percentage points)
Measured in percentage points.
Measured: From baseline (week 0) to week 104
Change in Short Form (SF)-36 Physical functioning score
Measured as score points. The 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. The scores are norm-based scores, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical Functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.
Measured: From baseline (week 0) to week 104
Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT): Physical Function Score
Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.
Measured: From baseline (week 0) to week 104
Change in IWQOL-Lite-CT: Physical Score
Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical score ranges from 0 to 100, with higher scores indicating better levels of functioning.
Measured: From baseline (week 0) to week 104
Change in IWQOL-Lite-CT: Psychosocial score
Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Psychosocial score ranges from 0 to 100, with higher scores indicating better levels of functioning.
Measured: From baseline (week 0) to week 104
Change in IWQOL-Lite-CT: Total score
Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Total score ranges from 0 to 100, with higher scores indicating better levels of functioning.
Measured: From baseline (week 0) to week 104
Change in Impact of Weight on Daily Activities Questionnaire (IWDAQ) Composite score
Measured as score points. IWDAQ is an 18-item measure that uses an adaptive design to provide a personalised assessment of daily activity limitations associated with excess weight. At the baseline assessment the study participants choose the 3 activities (items) they would most like to improve the weight loss and rate the degree of limitation in each of these activities. At follow-up assessments, the study participants again rate the degree of current limitation in each of the same 3 activities. The measure yields the IWDAQ composite score with a score range from 3 to 15 with higher scores indicating greater personalised activity limitation.
Measured: From baseline (week 0) to week 104
Change in Control of Eating questionnaire (CoEQ): Craving Control score
Measured as score points. CoEQ is a 19-item multidimensional patient reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.
Measured: From baseline (week 0) to week 104
Change in CoEQ: Positive Mood score
Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the Positive Mood subscale, item 6 'How anxious have you felt?' is reversed.
Measured: From baseline (week 0) to week 104
Change in CoEQ: Craving for Sweets score
Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving sweets food subscale, higher score represents a greater level of craving.
Measured: From baseline (week 0) to week 104
Change in CoEQ: Craving for Savoury score
Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving savoury food subscale, higher score represents a greater level of craving.
Measured: From baseline (week 0) to week 104
Change in CoEQ: Hunger score
Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the hunger subscale, higher score represents a greater level of craving.
Measured: From baseline (week 0) to week 104
Change in CoEQ: Satiety score
Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the satiety subscale, higher score represents a greater level of craving.
Measured: From baseline (week 0) to week 104
CagriSema s.c. 2.4 mg/2.4 mg versus placebo: Number of Treatment Emergent Adverse Events (TEAEs)
Measured as count of events.
Measured: From baseline (week 0) to week 104
CagriSema s.c. 2.4 mg/2.4 mg versus placebo: Number of Treatment Emergent Serious Adverse Events (TESAEs)
Measured as count of events.
Measured: From baseline (week 0) to week 104
CagriSema s.c. 2.4 mg/2.4 mg versus CagriSema s.c. dose tapering algorithm: Number of TEAEs
Measured as count of events.
Measured: From week 104 to end of study (week 162)
CagriSema s.c. 2.4 mg/2.4 mg versus CagriSema s.c. dose tapering algorithm: Number of TESAEs
Measured as count of events.
Measured: From week 104 to end of study (week 162)
CagriSema 2.4 mg/2.4 mg: Number of TEAEs
Measured as count of events.
Measured: From week 104 to end of study (week 162)
CagriSema 2.4 mg/2.4 mg: Number of TESAEs
Measured as count of events.
Measured: From week 104 to end of study (week 162)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start10 Feb 2025
- Primary completion28 Aug 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 400 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
- NCT06780449
- Sponsor's protocol ID
- NN9838-7859
- Other IDs
- U1111-1304-7430, 2024-512144-39
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2025
- Last updated
- 20 Jan 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Placebo in Participants With Obesity
- ClinicalTrials.gov ID
- NCT06780449
- Acronym / sponsor ID
- NN9838-7859
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 28 Aug 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 17 Jan 2025 (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 well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CagriSema | Experimental | Drug: Cagrilintide, Drug: SemaglutideParticipants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) after a dose escalation period of 16 weeks during the maintenance period for 88 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for one year. |
| Placebo | Placebo comparator | Drug: Placebo cagrilintide, Drug: Placebo semaglutideParticipants will receive placebo matched to cagrilintide and semaglutide subcutaneously once weekly for 104 weeks. Participants randomised to this arm will be included in the extension phase for one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female.
- Age above or equal to 18 years at the time of signing informed consent.
- Body mass index (BMI) greater than or equal to (>=) 35.0 kilograms per meter square (kg/m^2).
Key exclusion criteria (2 listed)
- Glycated haemoglobin (HbA1c) >= 6.5 percent (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes.
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 cagrilintide subcutaneously. | Drug | CagriSema |
| SemaglutideParticipants will receive semaglutide subcutaneously. | Drug | CagriSema |
| Placebo cagrilintideParticipants will receive placebo matched to cagrilintide subcutaneously. | Drug | Placebo |
| Placebo semaglutideParticipants will receive placebo matched to semaglutide subcutaneously. | Drug | Placebo |
Primary outcome
Relative change in body weight
Time frame: From baseline (week 0) to week 104
Measured in percentage (%).
59 secondary outcomes
Number of participants who achieve greater than or equal to (>=) 20 percent body weight reduction
Time frame: From baseline (week 0) to week 104
Number of participants who achieve >= 25 percent body weight reduction
Time frame: From baseline (week 0) to week 104
Number of participants who achieve >= 30 percent body weight reduction
Time frame: From baseline (week 0) to week 104
Change in waist circumference
Time frame: From baseline (week 0) to week 104
Change in waist to height ratio
Time frame: From baseline (week 0) to week 104
Change in Systolic Blood Pressure (SBP)
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Total Cholesterol
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Triglycerides
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Free fatty acids
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Non-HDL cholesterol
Time frame: From baseline (week 0) to week 104
Change in Body Mass Index (BMI)
Time frame: From baseline (week 0) to week 104
Number of participants who achieve BMI less than 30 kg/m^2
Time frame: At week 104
Change in Glycated Haemoglobin (HbA1c) (percentage points)
Time frame: From baseline (week 0) to week 104
Change in HbA1c (millimoles per mole [mmol/mol])
Time frame: From baseline (week 0) to week 104
Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])
Time frame: From baseline (week 0) to week 104
Change in FPG (milligrams per deciliter [mg/dL])
Time frame: From baseline (week 0) to week 104
Number of participants who achieve HbA1c less than (<) 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline
Time frame: From baseline (week 0) to week 104
Number of participants who achieve HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline
Time frame: From baseline (week 0) to week 104
Time to HbA1c < 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline
Time frame: From baseline (week 0) to week 104
Time to HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline
Time frame: From baseline (week 0) to week 104
Number of participants who develop HbA1c >= 5.7 percent or FPG greater than (>) 100 mg/dL with normoglycemia at baseline
Time frame: From baseline (week 0) to week 104
Number of participants who develop type 2 diabetes (T2D) as per American Diabetes Association (ADA) guideline
Time frame: From baseline (week 0) to week 104
Time to T2D diagnosis as per ADA guideline
Time frame: From baseline (week 0) to week 104
Change in American College of Cardiology/American Heart Association (ACC/AHA) 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk score
Time frame: From baseline (week 0) to week 104
Number of participants who improve in >= 1 pre-existing cardiometabolic obesity related com-plication (ORC) (hypertension, prediabetes, or dyslipidaemia)
Time frame: From baseline (week 0) to week 104
Ratio to baseline in C-reactive protein (CRP)
Time frame: From baseline (week 0) to week 104
Change in total fat mass by dual energy X-ray absorption (DXA) absolute to total body mass (kilogram [kg])
Time frame: From baseline (week 0) to week 104
Change in total fat mass by DXA relative to total body mass (kg)
Time frame: From baseline (week 0) to week 104
Change in total fat mass by DXA absolute to total body mass (percentage points)
Time frame: From baseline (week 0) to week 104
Change in total fat mass by DXA relative to total body mass (percentage points)
Time frame: From baseline (week 0) to week 104
Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage)
Time frame: From baseline (week 0) to week 104
Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage)
Time frame: From baseline (week 0) to week 104
Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage points)
Time frame: From baseline (week 0) to week 104
Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage points)
Time frame: From baseline (week 0) to week 104
Change in lean body mass by DXA absolute to total body mass (kg)
Time frame: From baseline (week 0) to week 104
Change in lean body mass by DXA relative to total body mass (kg)
Time frame: From baseline (week 0) to week 104
Change in lean body mass by DXA absolute to total body mass (percentage points)
Time frame: From baseline (week 0) to week 104
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 20 Jan 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.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. This study is not recruiting at the moment.
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 and Semaglutide in people with 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 3 inclusion and 2 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 20 Jan 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, United Kingdom, Portugal, Denmark, Belgium 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?
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 week 104). 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 20 Jan 2026; AzTrials last refreshed its copy on 27 Oct 2026.