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CompletedNCT04228354Updated Jan 10, 2022

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

A Phase 1 interventional study of Semaglutide in Healthy Volunteers, Overweight and Obesity, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-10.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
  • Overweight
  • Obesity
03

In context

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's enrollment of 28 is below the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

Browse Novo Nordisk A/S studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Semaglutide 0.68 mg/mL

    Semaglutide administered with the PDS290 pen-injector

    Drug: Semaglutide

  • Experimental
    Semaglutide 1.0 mg/mL

    Semaglutide administered with the PDS290 pen-injector

    Drug: Semaglutide

Interventions

  • DrugSemaglutide

    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

06

What researchers measure

Primary outcomes

  1. Area under the semaglutide plasma concentration curve from 0 to tz

    h\*nmol/L

    Time frame: 0-840 hours

  2. Maximum semaglutide plasma concentration

    nmol/L

    Time frame: 0-840 hours

Secondary outcomes

  1. Area under the semaglutide plasma concentration curve

    h\*nmol/L

    Time frame: 0-840 hours

  2. Time to Cmax for semaglutide

    h

    Time frame: 0-840 hours

  3. Terminal elimination half-life

    h

    Time frame: 0-840 hours

  4. Total apparent clearance of semaglutide

    L/h

    Time frame: 0-840 hours

  5. Apparent volume of distribution of semaglutide

    L

    Time frame: 0-840 hours

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Neuss, 41460, Germany
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Data sharing details ↗ · novonordisk-trials.com

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2020 to primary completion in Jun 2020, 4 months.

Of 237 industry-sponsored phase 1 interventional studies under Overweight, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 4 months is below that.

Counting every sponsor, half of 259 studies reached it within 9 months; a quarter within 5 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2020
First posted
Jan 14, 2020
StartActual
Jan 29, 2020
Primary completionActual
Jun 1, 2020
CompletionActual
Jun 1, 2020
Last update
Jan 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04228354
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jan 14, 2020
Start date
Jan 29, 2020
Primary completion
Jun 1, 2020
Completion
Jun 1, 2020
Last update
Jan 10, 2022

Study contacts

Clinical Reporting Anchor & Disclosure (1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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