ObesityPhase 1NCT06289504
A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight
A Phase 1 study testing Cagrilintide, Semaglutide and Atorvastatin in people with Obesity, run by Novo Nordisk A/S at 1 site in Canada.
Trial summary
This study will look at how CagriSema affects the blood levels of atorvastatin and warfarin. The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Cagrilintide, Semaglutide and Atorvastatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 27 Feb 2024to 15 Nov 2024
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female.
- Aged 18-65 years (both inclusive) at the time of signing informed consent.
- Body Mass Index (BMI) between 27.0 and 39.9 kilograms per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
Who cannot join
- Previous dosing in a study with an amylin analogue.
- Presence or history of pathological bleeding tendencies, recent serious bleeding, recent myopathy or rhabdomyolysis, malignant hypertension and any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions including type 1 or type 2 diabetes mellitus.
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
- Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole [mmol/mol]) at screening.
- Activated partial thromboplastin time (APTT) less than (<) 22.1 seconds (lower normal limit [LNL]-0%) or APTT greater than (>) 28.1 seconds (upper limit of normal [UNL) +0%) at screening.
- Prothrombin time < 70% (LNL-0%) or prothrombin time > 130% (UNL-0%) at screening.
- Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as perikon (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol and highly effective contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, One-sequence Cross-over, Single-centre Trial, Investigating the Influence of CagriSema on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Atorvastatin in Participants With Overweight or Obesity
This study will look at how CagriSema affects the blood levels of atorvastatin and warfarin. The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema. The study will also investigate the effect of warfarin before and after the participant takes CagriSema and assess if the injection site affects the level of CagriSema in the blood. The study will last for about 8 months.
- Conditions
- Obesity
- Being tested
- Cagrilintide, Semaglutide, Atorvastatin, Warfarin
- Medical subject headings
- 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 once weekly.
SemaglutideDrug
Semaglutide will be administered subcutaneously once weekly.
AtorvastatinDrug
Atorvastatin will be administered as a single dose orally 2 times during the study.
WarfarinDrug
Warfarin will be administered as a single dose orally 2 times during the study.
| Study group | Role | What they receive |
|---|---|---|
| CagriSema +Atorvastatin + Warfarin | Experimental | Participants will receive a single dose of atorvastatin and a single dose of warfarin followed by a 16-week CagriSema dose escalation period and a 7-week CagriSema maintenance period. Participants will also receive a single dose of atorvastatin and a single dose of warfarin in the maintenance period. Receives: Drug: Cagrilintide; Drug: Semaglutide; Drug: Atorvastatin; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-72hours,atorv,SD: Area under the atorvastatin plasma concentration-time curve from time 0 to 72 hours after a single dose of atorvastatin without CagriSema exposure and at CagriSema steady state
Measured in hours*nanomoles per liter (hours*nmol/L).
Measured: Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)
AUC0-168hours,S-war,SD: Area under the S-warfarin plasma concentration-time curve from time 0 to 168 hours after a single dose of warfarin without CagriSema exposure and at CagriSema steady state
Measured in hours*nmol/L.
Measured: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
Secondary outcomes (21)
AUC0-∞,atorv,SD: Area under the atorvastatin plasma concentration curve from time 0 to infinity after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state
Measured in hours*nmol/L.
Measured: Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)
Cmax,atorv,SD: Maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state
Measured in nanomoles per liter (nmol/L).
Measured: Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)
tmax,atorv,SD: Time to maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state
Measured in hours.
Measured: Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)
AUC0-∞,S-war,SD: Area under the S-warfarin plasma concentration curve from time 0 to infinity after single dose of warfarin without CagriSema exposure and at CagriSema steady state
Measured in hours*nmol/L.
Measured: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
Cmax,S-war,SD: Maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state
Measured in nmol/L.
Measured: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
tmax,S-war,SD: Time to maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state
Measured in hours.
Measured: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
iAUCINR,0-168hours: Incremental area under the INR-curve from 0 to 168 hours after single dose of warfarin without CagriSema exposure and at CagriSema steady state
Measured in hours*nmol/L.
Measured: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
INRmax: Maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state
Measured in ratio.
Measured: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
tINRmax: Time to maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state
Measured in hours.
Measured: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
Rac,0-168hours,cagri: The ratio of the area under the cagrilintide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose
Measured in ratio.
Measured: Day 23 (pre-dose to 168 hours post-dose) and day 44 (pre-dose to 168 hours post-dose)
Rac,0-168hours,sema: The ratio of the area under the semaglutide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose
Measured in ratio.
Measured: Day 23 (pre-dose to 168 hours post-dose) and day 44 (pre-dose to 168 hours post-dose
AUC0-168hours, 4th dose cagri: Area under the cagrilintide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema
Measured in hours*nmol/L.
Measured: Day 44 (pre-dose to 168 hours post-dose)
AUC0-168hours,4th dose Sema: Area under the semaglutide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema
Measured in hours*nmol/L.
Measured: Day 44 (pre-dose to 168 hours post-dose)
AUC0-168hours, cagri 2.4mg, SS: Area under the cagrilintide plasma concentration curve from 0 to 168 hours at steady state
Measured in hours*nmol/L.
Measured: Day 163 (pre-dose to 168 hours post-dose)
AUC0-168hours, sema 2.4mg, SS: Area under the semaglutide plasma concentration curve from 0 to 168 hours at steady state
Measured in hours*nmol/L.
Measured: Day 163 (pre-dose to 168 hours post-dose)
Cmax, cagri, SS: Maximum observed cagrilintide plasma concentration at steady state
Measured in nmol/L.
Measured: Day 163 (pre-dose to 168 hours post-dose)
tmax, cagri, SS: Time to maximum observed cagrilintide plasma concentration at steady state
Measured in hours.
Measured: Day 163 (pre-dose to 168 hours post-dose)
Cmax, sema,SS: Maximum observed semaglutide plasma concentration at steady state
Measured in nmol/L.
Measured: Day 163 (pre-dose to 168 hours post-dose)
tmax, sema, SS: Time to maximum observed semaglutide plasma concentration at steady state
Measured in hours.
Measured: Day 163 (pre-dose to 168 hours post-dose)
CL/Fcagri,SS: total apparent clearance of cagrilintide at steady state
Measured in litres per hour (L/h).
Measured: Day 163 (pre-dose to 168 hours post-dose)
CL/Fsema,SS: total apparent clearance of semaglutide at steady state
Measured in litres per hour (L/h).
Measured: Day 163 (pre-dose to 168 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start27 Feb 2024
- Primary completion16 Oct 2024
- Study completion15 Nov 2024
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT06289504
- Sponsor's protocol ID
- NN9838-4694
- Other IDs
- U1111-1295-4056
- Status last verified
- May 2026
- First submitted
- 25 Feb 2024
- Last updated
- 19 May 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, One-sequence Cross-over, Single-centre Trial, Investigating the Influence of CagriSema on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Atorvastatin in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06289504
- Acronym / sponsor ID
- NN9838-4694
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 4 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 CagriSema affects the blood levels of atorvastatin and warfarin. The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema. The study will also investigate the effect of warfarin before and after the participant takes CagriSema and assess if the injection site affects the level of CagriSema in the blood. The study will last for about 8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CagriSema +Atorvastatin + Warfarin | Experimental | Drug: Cagrilintide, Drug: Semaglutide, Drug: Atorvastatin, Drug: WarfarinParticipants will receive a single dose of atorvastatin and a single dose of warfarin followed by a 16-week CagriSema dose escalation period and a 7-week CagriSema maintenance period. Participants will also receive a single dose of atorvastatin and a single dose of warfarin in the maintenance period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female.
- Aged 18-65 years (both inclusive) at the time of signing informed consent.
- Body Mass Index (BMI) between 27.0 and 39.9 kilograms per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
Key exclusion criteria (7 listed)
- Previous dosing in a study with an amylin analogue.
- Presence or history of pathological bleeding tendencies, recent serious bleeding, recent myopathy or rhabdomyolysis, malignant hypertension and any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions including type 1 or type 2 diabetes mellitus.
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
- Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole [mmol/mol]) at screening.
- Activated partial thromboplastin time (APTT) less than (<) 22.1 seconds (lower normal limit [LNL]-0%) or APTT greater than (>) 28.1 seconds (upper limit of normal [UNL) +0%) at 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 once weekly. | Drug | CagriSema +Atorvastatin + Warfarin |
| SemaglutideSemaglutide will be administered subcutaneously once weekly. | Drug | CagriSema +Atorvastatin + Warfarin |
| AtorvastatinAtorvastatin will be administered as a single dose orally 2 times during the study. | Drug | CagriSema +Atorvastatin + Warfarin |
| WarfarinWarfarin will be administered as a single dose orally 2 times during the study. | Drug | CagriSema +Atorvastatin + Warfarin |
Primary outcome
AUC0-72hours,atorv,SD: Area under the atorvastatin plasma concentration-time curve from time 0 to 72 hours after a single dose of atorvastatin without CagriSema exposure and at CagriSema steady state
Time frame: Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)
Measured in hours*nanomoles per liter (hours*nmol/L).
AUC0-168hours,S-war,SD: Area under the S-warfarin plasma concentration-time curve from time 0 to 168 hours after a single dose of warfarin without CagriSema exposure and at CagriSema steady state
Time frame: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
Measured in hours*nmol/L.
21 secondary outcomes
AUC0-∞,atorv,SD: Area under the atorvastatin plasma concentration curve from time 0 to infinity after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state
Time frame: Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)
Cmax,atorv,SD: Maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state
Time frame: Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)
tmax,atorv,SD: Time to maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state
Time frame: Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)
AUC0-∞,S-war,SD: Area under the S-warfarin plasma concentration curve from time 0 to infinity after single dose of warfarin without CagriSema exposure and at CagriSema steady state
Time frame: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
Cmax,S-war,SD: Maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state
Time frame: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
tmax,S-war,SD: Time to maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state
Time frame: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
iAUCINR,0-168hours: Incremental area under the INR-curve from 0 to 168 hours after single dose of warfarin without CagriSema exposure and at CagriSema steady state
Time frame: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
INRmax: Maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state
Time frame: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
tINRmax: Time to maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state
Time frame: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
Rac,0-168hours,cagri: The ratio of the area under the cagrilintide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose
Time frame: Day 23 (pre-dose to 168 hours post-dose) and day 44 (pre-dose to 168 hours post-dose)
Rac,0-168hours,sema: The ratio of the area under the semaglutide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose
Time frame: Day 23 (pre-dose to 168 hours post-dose) and day 44 (pre-dose to 168 hours post-dose
AUC0-168hours, 4th dose cagri: Area under the cagrilintide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema
Time frame: Day 44 (pre-dose to 168 hours post-dose)
AUC0-168hours,4th dose Sema: Area under the semaglutide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema
Time frame: Day 44 (pre-dose to 168 hours post-dose)
AUC0-168hours, cagri 2.4mg, SS: Area under the cagrilintide plasma concentration curve from 0 to 168 hours at steady state
Time frame: Day 163 (pre-dose to 168 hours post-dose)
AUC0-168hours, sema 2.4mg, SS: Area under the semaglutide plasma concentration curve from 0 to 168 hours at steady state
Time frame: Day 163 (pre-dose to 168 hours post-dose)
Cmax, cagri, SS: Maximum observed cagrilintide plasma concentration at steady state
Time frame: Day 163 (pre-dose to 168 hours post-dose)
tmax, cagri, SS: Time to maximum observed cagrilintide plasma concentration at steady state
Time frame: Day 163 (pre-dose to 168 hours post-dose)
Cmax, sema,SS: Maximum observed semaglutide plasma concentration at steady state
Time frame: Day 163 (pre-dose to 168 hours post-dose)
tmax, sema, SS: Time to maximum observed semaglutide plasma concentration at steady state
Time frame: Day 163 (pre-dose to 168 hours post-dose)
CL/Fcagri,SS: total apparent clearance of cagrilintide at steady state
Time frame: Day 163 (pre-dose to 168 hours post-dose)
CL/Fsema,SS: total apparent clearance of semaglutide at steady state
Time frame: Day 163 (pre-dose to 168 hours post-dose)
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 19 May 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cagrilintide, Semaglutide and Atorvastatin in people with Obesity, run by Novo Nordisk A/S at 1 site in Canada.
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 7 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
AUC0-72hours,atorv,SD: Area under the atorvastatin plasma concentration-time curve from time 0 to 72 hours after a single dose of atorvastatin without CagriSema exposure and at CagriSema steady state (time frame: Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)). The study lists 2 primary outcomes in all. 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 19 May 2026.