Clinical trial NCT05689099: A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose
Official title: A Study to Demonstrate Bioequivalence Between Semaglutide Drug Product Concentrations 0.68 mg/mL and 1.34 mg/mL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Healthy Participants
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study, a known investigational medicine called 'semaglutide' will be tested in 2 drug concentrations of 0.68 milligram per milliliter (mg/mL) and 1.34 mg/mL. Both drug concentrations are tested for the treatment of type 2 diabetes. The U.S. Food and Drug Administration (FDA), has approved semaglutide in prefilled pen-injector form. Currently, the drug concentration of 1.34 mg/ml can be prescribed in some countries including U.S. The objective of the study is to compare the amount of investigational drug taken up in the body for the 2 drug concentrations. Participants will be divided by chance into 2 groups. Group A will receive a single dose of 0.5 mg semaglutide of the drug concentration 1.34 mg/mL in the first study period; and will receive a single dose of 0.5 mg semaglutide of the drug concentration 0.68 mg/mL in the second study period. Participants assigned to group B will receive the two drug concentrations in the reverse order. Participants will get 1 subcutaneous injection on Day 1 of each of the two study periods. The two injections are separated by 7-11 weeks. The study will last up to approximately 87 to 141 days for each participant. This includes a screening period (up to 4 weeks), study period 1 (5 weeks), washout period (2-6 weeks), and study period 2 (5 weeks). At some periods during the study, participant should not get vaccinations. Participant should agree on timing of vaccination with study doctor. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 20.0 and 29.9 kilograms per meter square (kg/m\^2) (both inclusive)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
* Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol, ibuprofen and acetylsalicylic acid, within 14 days prior to the day of screening
* Abuse or intake of alcohol, defined as any of the below:

  1. Known or suspected alcohol abuse within 1 year before screening (defined as regular intake of more than an average intake of 24 grams (g) alcohol daily for men and 12 g alcohol daily for women - 12 g of alcohol equals about 300 milliliters (mL) of beer or lager, 100 mL of wine, or 25 mL spirits)
  2. Positive alcohol test at screening
* Abuse or intake of drugs, defined as any of the below:

  1. Known or suspected drug or chemical substance abuse within 1 year before screening
  2. Positive drug of abuse test at screening

Primary outcomes:
measure: AUC0-last,sema 0.5mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after single dose of subcutaneous semaglutide 0.5 mg
timeFrame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
measure: Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of subcutaneous semaglutide 0.5 mg administration
timeFrame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical LA, Inc.
state: California
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: