A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide

NCT04228354 | Completed Phase 1

• 3 other identifiers: NN9536-4649U1111-1241-62572019-004020-37
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Conditions

Healthy Volunteers; Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• Area under the semaglutide plasma concentration curve from 0 to tz

  h\*nmol/L

  0-840 hours

• Maximum semaglutide plasma concentration

  nmol/L

  0-840 hours

Secondary Outcomes (5)

• Area under the semaglutide plasma concentration curve

  0-840 hours

• Time to Cmax for semaglutide

  0-840 hours

• Terminal elimination half-life

  0-840 hours

• Total apparent clearance of semaglutide

  0-840 hours

• Apparent volume of distribution of semaglutide

  0-840 hours

Study Arms (2)

Semaglutide 0.68 mg/mL

EXPERIMENTAL

Semaglutide administered with the PDS290 pen-injector

Drug: Semaglutide

Semaglutide 1.0 mg/mL

EXPERIMENTAL

Semaglutide administered with the PDS290 pen-injector

Drug: Semaglutide

Interventions

Semaglutide DRUG

Two doses of semaglutide given by subcutaneous (s.c., under the skin) injection with different drug product concentration and separated by 6 to 8 weeks

Semaglutide 0.68 mg/mL; Semaglutide 1.0 mg/mL

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 between 20.0 and 27.0 kg/m\^2 (both inclusive).

You may not qualify if:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Reporting Anchor & Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 14, 2020
• Study Start: January 29, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)