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Recruiting NCT05689099

A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose

Conditions: Diabetes Mellitus, Type 2, Healthy Participants

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 20
Sponsor: Novo Nordisk A/S

Location: United States

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 femaleAged 18-55 years (both inclusive) at the time of signing informed consentBody 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 methodAny disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocolUse 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 screeningAbuse or intake of alcohol, defined as any of the below: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)Positive alcohol test at screeningAbuse or intake of drugs, defined as any of the below:Known or suspected drug or chemical substance abuse within 1 year before screeningPositive drug of abuse test at screening

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05689099). StuddyBuddy aggregates publicly available trial information.