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NCT Number: NCT07769489

Study to Assess Tolerability of Injecting Larger Volumes (2-5 mL) Subcutaneously at Different Rates: Participant Experience and Acceptance

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.

Recruiting

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Clinical Innovation Centre A/S

Gentofte Municipality, 2820, Denmark

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Syringe Pump

Device

Device used for delivery of subcutaneous injections and infusions of NaCl solution.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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

    Measured as binary response (Acceptable/Not acceptable).

  2. Back flow at the injection site

    Time frame: 5 minutes (±1 minute) from the injection initiation

    Measured in microlitres (μL).

  3. 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

    Measured in injection site reactions (events).

  4. 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

    Measured in injection site reactions (events).

  5. 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

    Measured in events.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Exploratory Study to Investigate Pain Related to Injection of Large Volumes (up to 5mL) Subcutaneously

Acronym: RISE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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