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

NCT05689099 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9535-7560U1111-1280-1368
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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

  Measured in hours\*nanomoles per liter (h\*nmol/L).

  0-840 hours after a single dose of s.c. semaglutide 0.5 mg

• Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of subcutaneous semaglutide 0.5 mg administration

  Measured in nanomoles per liter (nmol/L).

  0-840 hours after a single dose of s.c. semaglutide 0.5 mg

Study Arms (2)

Sequence A

EXPERIMENTAL

Participants will be administered a single subcutaneous (s.c.) dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 2.

Drug: Semaglutide B, 1.34 mg/mL; Drug: Semaglutide B, 0.68 mg/mL

Sequence B

EXPERIMENTAL

Participants will be administered a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 2.

Drug: Semaglutide B, 1.34 mg/mL; Drug: Semaglutide B, 0.68 mg/mL

Interventions

Semaglutide B, 1.34 mg/mL DRUG

Participants will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.

Sequence A; Sequence B

Semaglutide B, 0.68 mg/mL DRUG

Participants will receive single dose of 0.5 mg Semaglutide B, 0.68 mg/mL subcutaneously.

Sequence A; Sequence B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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:
• 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 screening
• Abuse or intake of drugs, defined as any of the below:
• Known or suspected drug or chemical substance abuse within 1 year before screening
• Positive drug of abuse test at screening

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Altasciences Clinical LA, Inc.

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: January 17, 2023
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)