A Phase 1 interventional study of Trial product 1 and Trial product 2 in Obesity, sponsored by Novo Nordisk A/S. Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Other
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.
Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
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
Intensity of injection site pain
mm on a 100 mm horizontal visual-analogue scale (where 0 mm = no pain, 100 mm = unbearable pain)
Time frame: 1 min after each injection (Day 1 and Day 2)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S