Healthy ParticipantsPhase 1RISENCT07769489
Study to Assess Tolerability of Injecting Larger Volumes (2-5 mL) Subcutaneously at Different Rates: Participant Experience and Acceptance
A Phase 1 study testing Syringe Pump in people with Healthy Participants, run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
The purpose of the study is to investigate the tolerability of different injection/infusion volumes and speed compared to standard practise. The order in which the different volumes and injection speeds will be given to participants will be allocated by chance. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Syringe Pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Aug 2026to 11 Dec 2026
- Phase
- Phase 1
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Healthy male or female participants as judged by the investigator.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body Mass Index (BMI) greater than or equal to (>=) 18.5 and less than or equal to (<=) 30.0 kilograms per square metre (kg/m^2) (both included).
- White (Light skin that allows for adequate medical evaluation of any skin reactions).
Who cannot join
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous randomisation in this study.
- Previous rescreening for this study.
- Pregnant or breastfeeding female participants.
- Current participation (i.e., signed informed consent) in any other interventional clinical study. Treatment with an investigational medical product within 3 months or 5 half-lives (if known), whichever is longer prior to screening.
- Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol, including insufficient abdominal area for injection.
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- Intake of any medication that could influence pain perception or injection site reaction appearance (e.g., anti-coagulants, including low dose of aspirin, systemic antihistamines, pain-relieving, or anti-inflammatory medicinal products) within the last week before the intervention.
- Intake of alcohol within the last 24 hours (self-reported) or a positive result of alcohol breath test prior to randomisation and intervention.
- Intake of illicit drugs within the last 48 hours (self-reported) or a positive result of urine drug screening prior to screening.
- Use of any nicotine products within the past month before screening.
- Known active or inactive skin condition or disease, tattoos, or other interventions in the injection area that may affect pain perception or assessment of injection-site reactions.
- Strenuous exercise within 3 days prior to the intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Novo Nordisk Clinical Innovation Centre A/S
Gentofte Municipality, 2820
About this study
Official title: An Exploratory Study to Investigate Pain Related to Injection of Large Volumes (up to 5mL) Subcutaneously
The purpose of the study is to investigate the tolerability of different injection/infusion volumes and speed compared to standard practise. The order in which the different volumes and injection speeds will be given to participants will be allocated by chance. Participants will be in this clinical study for about 1 week.
- Conditions
- Healthy Participants
- Being tested
- Syringe Pump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syringe PumpDevice
Device used for delivery of subcutaneous injections and infusions of NaCl solution.
| Study group | Role | What they receive |
|---|---|---|
| Pilot cohort | Experimental | Participants will receive subcutaneous injections and infusions of sodium chloride (NaCl) solution in varying combinations of speed and volume at different abdominal sites in a randomised sequence. A syringe pump with an attached syringe will be used for delivery of subcutaneous injections and infusions. Receives: Device: Syringe Pump |
| Main cohort | Experimental | Participants will receive subcutaneous injections and infusions of sodium chloride (NaCl) solution in varying combinations of speed and volume (that have passed safety assessment in pilot cohort) at different abdominal sites in a randomised sequence. A syringe pump with an attached syringe will be used for delivery of subcutaneous injections and infusions. Receives: Device: Syringe Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection pain rated on a Visual Analogue Scale (VAS)
The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in millimetres (mm).
Measured: 1 minute (±1 minute) from the injection initiation
Injection pain rated on a VAS
The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in mm.
Measured: 9 minutes (±1minute) from the injection initiation
Secondary outcomes (5)
Acceptance of pain for each injection (including the needle insertions only) as a binary measure
Measured as binary response (Acceptable/Not acceptable).
Measured: 1 minute (±1 minute) from the injection initiation
Back flow at the injection site
Measured in microlitres (μL).
Measured: 5 minutes (±1 minute) from the injection initiation
Number of acute injection site reactions (haematoma, haemorrhage, bruising, erythema and oedema formation) after each injection
Measured in injection site reactions (events).
Measured: 9 minutes (±1 minute) from the injection initiation
Number of long term injection site reactions (haematoma, haemorrhage, bruising, erythema and oedema formation)
Measured in injection site reactions (events).
Measured: 16-40 hours after all injections with an additional 36 hours if a clinic visit is needed
Number of adverse events
Measured in events.
Measured: Up to 40 hours after completing all the injections with an additional 36 hours if a clinic visit is needed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start17 Aug 2026
- Primary completion9 Dec 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Sponsor staff involved in the clinical trial is masked according to company standard procedures. Sponsor is unblinded.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 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
- NCT07769489
- Sponsor's protocol ID
- EX0700-8681
- Other IDs
- U1111-1336-6170
- Acronym
- RISE
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Investigate Pain Related to Injection of Large Volumes (up to 5mL) Subcutaneously
- ClinicalTrials.gov ID
- NCT07769489
- Acronym / sponsor ID
- RISE / EX0700-8681
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 9 Dec 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the tolerability of different injection/infusion volumes and speed compared to standard practise. The order in which the different volumes and injection speeds will be given to participants will be allocated by chance. Participants will be in this clinical study for about 1 week.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sponsor staff involved in the clinical trial is masked according to company standard procedures. Sponsor is unblinded.
| Arm | Type | Receives |
|---|---|---|
| Pilot cohort | Experimental | Device: Syringe PumpParticipants will receive subcutaneous injections and infusions of sodium chloride (NaCl) solution in varying combinations of speed and volume at different abdominal sites in a randomised sequence. A syringe pump with an attached syringe will be used for delivery of subcutaneous injections and infusions. |
| Main cohort | Experimental | Device: Syringe PumpParticipants will receive subcutaneous injections and infusions of sodium chloride (NaCl) solution in varying combinations of speed and volume (that have passed safety assessment in pilot cohort) at different abdominal sites in a randomised sequence. A syringe pump with an attached syringe will be used for delivery of subcutaneous injections and infusions. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Healthy male or female participants as judged by the investigator.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body Mass Index (BMI) greater than or equal to (>=) 18.5 and less than or equal to (<=) 30.0 kilograms per square metre (kg/m^2) (both included).
- White (Light skin that allows for adequate medical evaluation of any skin reactions).
Key exclusion criteria (12 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous randomisation in this study.
- Previous rescreening for this study.
- Pregnant or breastfeeding female participants.
- Current participation (i.e., signed informed consent) in any other interventional clinical study. Treatment with an investigational medical product within 3 months or 5 half-lives (if known), whichever is longer prior to 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 |
|---|---|---|
| Syringe PumpDevice used for delivery of subcutaneous injections and infusions of NaCl solution. | Device | Main cohort, Pilot cohort |
Primary outcome
Injection pain rated on a Visual Analogue Scale (VAS)
Time frame: 1 minute (±1 minute) from the injection initiation
The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in millimetres (mm).
Injection pain rated on a VAS
Time frame: 9 minutes (±1minute) from the injection initiation
The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in mm.
5 secondary outcomes
Acceptance of pain for each injection (including the needle insertions only) as a binary measure
Time frame: 1 minute (±1 minute) from the injection initiation
Back flow at the injection site
Time frame: 5 minutes (±1 minute) from the injection initiation
Number of acute injection site reactions (haematoma, haemorrhage, bruising, erythema and oedema formation) after each injection
Time frame: 9 minutes (±1 minute) from the injection initiation
Number of long term injection site reactions (haematoma, haemorrhage, bruising, erythema and oedema formation)
Time frame: 16-40 hours after all injections with an additional 36 hours if a clinic visit is needed
Number of adverse events
Time frame: Up to 40 hours after completing all the injections with an additional 36 hours if a clinic visit is needed
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 15 Sep 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.
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 Syringe Pump in people with Healthy Participants, run by Novo Nordisk A/S at 1 site in Denmark.
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 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 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 1 site in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injection pain rated on a Visual Analogue Scale (VAS) (time frame: 1 minute (±1 minute) from the injection initiation). 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 15 Sep 2026.