ObesityPhase 1NCT04482725

Injection Site Pain Comparison of Excipient Solutions

A Phase 1 study testing Trial product 1, Trial product 2 and Trial product 3 in people with Obesity, run by Novo Nordisk A/S at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Trial product 1, Trial product 2 and Trial product 3
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 1 siteNetherlands
Study dates: 20 Jul 2020to 25 Sep 2020
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Male or female, aged 18 to 69 years (both inclusive) at the time of signing informed consent.
Body Mass Index (BMI) equal to or above 25.0 and below 30.0 kg/m^2.
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the Investigator.

Who cannot join

Female who is pregnant, breast-feeding or intends to become pregnant within 1 week of Day 2 or is of childbearing potential and not using highly effective contraceptive methods.
Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Glycated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.
Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication (when not used in the abdominal area), contraceptives or occasional use of paracetamol (not allowed within 24 hours prior to Trial Product administration), within 14 days prior to Day 1.
Average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research centre.

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Use of tobacco and nicotine products, defined as any of the below:
Smoking more than 1 cigarette or the equivalent per day on average.
Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period.
Subject is not able to understand and read English or Dutch, or subject is not able to understand and comply with the trial requirements.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Novo Nordisk Investigational Site
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A Trial to Assess the Injection Site Pain Experience of Excipient Solutions Relevant for Subcutaneous Injection

The purpose of this study is to investigate different solutions used to inject drugs under the skin. The solutions used in the study do not contain the drugs they will be used for, but they do contain excipients, which are inactive substances added to drug solutions to ensure the stability (shelf life and correct activity) of the drug product. The excipients are considered 'inactive substances' compared to the drug, but they may cause an undesirable effect at the injection site in the form of pain. However, their pain-causing potential has never been tested in a systematic way. The purpose of the study is to determine if there is a difference in the injection site pain experience after an injection under the skin (subcutaneous) with 12 different study products. These study products are excipient solutions, which are substances in medications next to the active substance. None of the 12 products include active medication. This study will be performed in 108 healthy male and female volunteers.

Conditions: Obesity
Being tested: Trial product 1, Trial product 2, Trial product 3, Trial product 4, Trial product 5
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trial product 1Other
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Trial product 2Other
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Trial product 3Other
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Trial product 4Other
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Trial product 5Other
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Trial product 6Other
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Trial product 7Other
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Trial product 8Other
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Trial product 9Other
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Trial product 10Other
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Trial product 10Other
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Trial product 12Other
Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL

Study groups in NCT04482725
Study group	Role	What they receive
S1	Experimental	Day 1: Trial products 1-2-12-3-11-4 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 10-5-9-6-8-7 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Receives: Other: Trial product 1; Other: Trial product 2; Other: Trial product 3; Other: Trial product 4; Other: Trial product 5; Other: Trial product 6; Other: Trial product 7; Other: Trial product 8; Other: Trial product 9; Other: Trial product 10; Other: Trial product 12
S2	Experimental	Day 1: Trial products 2-3-1-4-12-5 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 11-6-10-7-9-8 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Receives: Other: Trial product 1; Other: Trial product 2; Other: Trial product 3; Other: Trial product 4; Other: Trial product 5; Other: Trial product 6; Other: Trial product 7; Other: Trial product 8; Other: Trial product 9; Other: Trial product 10; Other: Trial product 12
S3	Experimental	Day 1: Trial products 3-4-2-5-1-6 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 12-7-11-8-10-9 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Receives: Other: Trial product 1; Other: Trial product 2; Other: Trial product 3; Other: Trial product 4; Other: Trial product 5; Other: Trial product 6; Other: Trial product 7; Other: Trial product 8; Other: Trial product 9; Other: Trial product 10; Other: Trial product 12
S4	Experimental	Day 1: Trial products 4-5-3-6-2-7 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 1-8-12-9-11-10 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Receives: Other: Trial product 1; Other: Trial product 2; Other: Trial product 3; Other: Trial product 4; Other: Trial product 5; Other: Trial product 6; Other: Trial product 7; Other: Trial product 8; Other: Trial product 9; Other: Trial product 10; Other: Trial product 12
S5	Experimental	Day 1: Trial products 5-6-4-7-3-8 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 2-9-1-10-12-11 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Receives: Other: Trial product 1; Other: Trial product 2; Other: Trial product 3; Other: Trial product 4; Other: Trial product 5; Other: Trial product 6; Other: Trial product 7; Other: Trial product 8; Other: Trial product 9; Other: Trial product 10; Other: Trial product 12
S6	Experimental	Day 1: Trial products 6-7-5-8-4-9 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 3-10-2-11-1-12 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Receives: Other: Trial product 1; Other: Trial product 2; Other: Trial product 3; Other: Trial product 4; Other: Trial product 5; Other: Trial product 6; Other: Trial product 7; Other: Trial product 8; Other: Trial product 9; Other: Trial product 10; Other: Trial product 12
S7	Experimental	Day 1: Trial products 7-8-6-9-5-10 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 4-11-3-12-2-1-given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Receives: Other: Trial product 1; Other: Trial product 2; Other: Trial product 3; Other: Trial product 4; Other: Trial product 5; Other: Trial product 6; Other: Trial product 7; Other: Trial product 8; Other: Trial product 9; Other: Trial product 10; Other: Trial product 12
S8	Experimental	Day 1: Trial products 8-9-7-10-6-11 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 5-12-4-1-3-2 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Receives: Other: Trial product 1; Other: Trial product 2; Other: Trial product 3; Other: Trial product 4; Other: Trial product 5; Other: Trial product 6; Other: Trial product 7; Other: Trial product 8; Other: Trial product 9; Other: Trial product 10; Other: Trial product 12
S9	Experimental	Day 1: Trial products 9-10-8-11-7-12 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 6-1-5-2-4-3 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Receives: Other: Trial product 1; Other: Trial product 2; Other: Trial product 3; Other: Trial product 4; Other: Trial product 5; Other: Trial product 6; Other: Trial product 7; Other: Trial product 8; Other: Trial product 9; Other: Trial product 10; Other: Trial product 12
S10	Experimental	Day 1: Trial products 10-11-9-12-8-1 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 7-2-6-3-5-4 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Receives: Other: Trial product 1; Other: Trial product 2; Other: Trial product 3; Other: Trial product 4; Other: Trial product 5; Other: Trial product 6; Other: Trial product 7; Other: Trial product 8; Other: Trial product 9; Other: Trial product 10; Other: Trial product 12
S11	Experimental	Day 1: Trial products 11-12-10-1-9-2 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 8-3-7-4-6-5 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Receives: Other: Trial product 1; Other: Trial product 2; Other: Trial product 3; Other: Trial product 4; Other: Trial product 5; Other: Trial product 6; Other: Trial product 7; Other: Trial product 8; Other: Trial product 9; Other: Trial product 10; Other: Trial product 12
S12	Experimental	Day 1: Trial products 12-1-11-2-10-3 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 9-4-8-5-7-6 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Receives: Other: Trial product 1; Other: Trial product 2; Other: Trial product 3; Other: Trial product 4; Other: Trial product 5; Other: Trial product 6; Other: Trial product 7; Other: Trial product 8; Other: Trial product 9; Other: Trial product 10; Other: Trial product 12

What is being measured

The primary outcome is the main question the study is designed to answer.

Intensity of injection site pain
mm on a 100 mm horizontal visual-analogue scale (where 0 mm
= no pain, 100 mm = unbearable pain)
Measured: 1 min after each injection (Day 1 and Day 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 202025 Sep 2020

First posted22 Jul 2020
Study start20 Jul 2020
Primary completion24 Sep 2020
Study completion25 Sep 2020

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: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04482725
Sponsor's protocol ID: NN9838-4703
Other IDs: U1111-1250-7817
Status last verified: Oct 2021
First submitted: 20 Jul 2020
Last updated: 19 Oct 2021
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Metabolic Abnormalities, Obesity & Overweight
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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial to Assess the Injection Site Pain Experience of Excipient Solutions Relevant for Subcutaneous Injection
ClinicalTrials.gov ID: NCT04482725
Acronym / sponsor ID: NN9838-4703
Conditions: Obesity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 20 Jul 2020 (actual)
Primary completion: 24 Sep 2020 (actual)
Study completion: 25 Sep 2020 (actual)
First posted: 22 Jul 2020 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 12

Arm	Type	Receives
S1	Experimental	Other: Trial product 1, Other: Trial product 2, Other: Trial product 3, Other: Trial product 4, Other: Trial product 5, Other: Trial product 6, Other: Trial product 7, Other: Trial product 8, Other: Trial product 9, Other: Trial product 10, Other: Trial product 12Day 1: Trial products 1-2-12-3-11-4 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 10-5-9-6-8-7 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
S2	Experimental	Other: Trial product 1, Other: Trial product 2, Other: Trial product 3, Other: Trial product 4, Other: Trial product 5, Other: Trial product 6, Other: Trial product 7, Other: Trial product 8, Other: Trial product 9, Other: Trial product 10, Other: Trial product 12Day 1: Trial products 2-3-1-4-12-5 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 11-6-10-7-9-8 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
S3	Experimental	Other: Trial product 1, Other: Trial product 2, Other: Trial product 3, Other: Trial product 4, Other: Trial product 5, Other: Trial product 6, Other: Trial product 7, Other: Trial product 8, Other: Trial product 9, Other: Trial product 10, Other: Trial product 12Day 1: Trial products 3-4-2-5-1-6 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 12-7-11-8-10-9 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
S4	Experimental	Other: Trial product 1, Other: Trial product 2, Other: Trial product 3, Other: Trial product 4, Other: Trial product 5, Other: Trial product 6, Other: Trial product 7, Other: Trial product 8, Other: Trial product 9, Other: Trial product 10, Other: Trial product 12Day 1: Trial products 4-5-3-6-2-7 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 1-8-12-9-11-10 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
S5	Experimental	Other: Trial product 1, Other: Trial product 2, Other: Trial product 3, Other: Trial product 4, Other: Trial product 5, Other: Trial product 6, Other: Trial product 7, Other: Trial product 8, Other: Trial product 9, Other: Trial product 10, Other: Trial product 12Day 1: Trial products 5-6-4-7-3-8 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 2-9-1-10-12-11 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
S6	Experimental	Other: Trial product 1, Other: Trial product 2, Other: Trial product 3, Other: Trial product 4, Other: Trial product 5, Other: Trial product 6, Other: Trial product 7, Other: Trial product 8, Other: Trial product 9, Other: Trial product 10, Other: Trial product 12Day 1: Trial products 6-7-5-8-4-9 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 3-10-2-11-1-12 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
S7	Experimental	Other: Trial product 1, Other: Trial product 2, Other: Trial product 3, Other: Trial product 4, Other: Trial product 5, Other: Trial product 6, Other: Trial product 7, Other: Trial product 8, Other: Trial product 9, Other: Trial product 10, Other: Trial product 12Day 1: Trial products 7-8-6-9-5-10 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 4-11-3-12-2-1-given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
S8	Experimental	Other: Trial product 1, Other: Trial product 2, Other: Trial product 3, Other: Trial product 4, Other: Trial product 5, Other: Trial product 6, Other: Trial product 7, Other: Trial product 8, Other: Trial product 9, Other: Trial product 10, Other: Trial product 12Day 1: Trial products 8-9-7-10-6-11 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 5-12-4-1-3-2 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
S9	Experimental	Other: Trial product 1, Other: Trial product 2, Other: Trial product 3, Other: Trial product 4, Other: Trial product 5, Other: Trial product 6, Other: Trial product 7, Other: Trial product 8, Other: Trial product 9, Other: Trial product 10, Other: Trial product 12Day 1: Trial products 9-10-8-11-7-12 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 6-1-5-2-4-3 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
S10	Experimental	Other: Trial product 1, Other: Trial product 2, Other: Trial product 3, Other: Trial product 4, Other: Trial product 5, Other: Trial product 6, Other: Trial product 7, Other: Trial product 8, Other: Trial product 9, Other: Trial product 10, Other: Trial product 12Day 1: Trial products 10-11-9-12-8-1 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 7-2-6-3-5-4 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
S11	Experimental	Other: Trial product 1, Other: Trial product 2, Other: Trial product 3, Other: Trial product 4, Other: Trial product 5, Other: Trial product 6, Other: Trial product 7, Other: Trial product 8, Other: Trial product 9, Other: Trial product 10, Other: Trial product 12Day 1: Trial products 11-12-10-1-9-2 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 8-3-7-4-6-5 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
S12	Experimental	Other: Trial product 1, Other: Trial product 2, Other: Trial product 3, Other: Trial product 4, Other: Trial product 5, Other: Trial product 6, Other: Trial product 7, Other: Trial product 8, Other: Trial product 9, Other: Trial product 10, Other: Trial product 12Day 1: Trial products 12-1-11-2-10-3 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen. Day 2: Trial products 9-4-8-5-7-6 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Male or female, aged 18 to 69 years (both inclusive) at the time of signing informed consent.
Body Mass Index (BMI) equal to or above 25.0 and below 30.0 kg/m^2.
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the Investigator.

Key exclusion criteria (10 listed)

Female who is pregnant, breast-feeding or intends to become pregnant within 1 week of Day 2 or is of childbearing potential and not using highly effective contraceptive methods.
Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Glycated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.
Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication (when not used in the abdominal area), contraceptives or occasional use of paracetamol (not allowed within 24 hours prior to Trial Product administration), within 14 days prior to Day 1.
Average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.

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
Trial product 1Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL	Other	S1, S10, S11, S12, S2, S3, S4, S5, S6, S7, S8, S9
Trial product 2Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL	Other	S1, S10, S11, S12, S2, S3, S4, S5, S6, S7, S8, S9
Trial product 3Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL	Other	S1, S10, S11, S12, S2, S3, S4, S5, S6, S7, S8, S9
Trial product 4Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL	Other	S1, S10, S11, S12, S2, S3, S4, S5, S6, S7, S8, S9
Trial product 5Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL	Other	S1, S10, S11, S12, S2, S3, S4, S5, S6, S7, S8, S9
Trial product 6Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL	Other	S1, S10, S11, S12, S2, S3, S4, S5, S6, S7, S8, S9
Trial product 7Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL	Other	S1, S10, S11, S12, S2, S3, S4, S5, S6, S7, S8, S9
Trial product 8Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL	Other	S1, S10, S11, S12, S2, S3, S4, S5, S6, S7, S8, S9
Trial product 9Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL	Other	S1, S10, S11, S12, S2, S3, S4, S5, S6, S7, S8, S9
Trial product 10Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL	Other	S1, S10, S11, S12, S2, S3, S4, S5, S6, S7, S8, S9
Trial product 10Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL	Other	S1, S10, S11, S12, S2, S3, S4, S5, S6, S7, S8, S9
Trial product 12Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL	Other	S1, S10, S11, S12, S2, S3, S4, S5, S6, S7, S8, S9

Primary outcome

Intensity of injection site pain
Time frame: 1 min after each injection (Day 1 and Day 2)
mm on a 100 mm horizontal visual-analogue scale (where 0 mm = no pain, 100 mm = unbearable pain)

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 Oct 2021.
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 Reporting Anchor and Disclosur (1452) 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 Trial product 1, Trial product 2 and Trial product 3 in people with Obesity, run by Novo Nordisk A/S at 1 site in Netherlands.

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 10 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 Oct 2021. 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 Netherlands. 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?

Intensity of injection site pain (time frame: 1 min after each injection (Day 1 and Day 2)). 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 NCT04482725.

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 Oct 2021.