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OverweightPhase 1NCT04187300

A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

A Phase 1 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight, Obesity
What is being tested?
Semaglutide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteGermany
Study dates
16 Dec 2019to 23 Sep 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
  • Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive)
  • Body weight between 70.0 and 130.0 kg (both inclusive)

Who cannot join

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
  • Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
  • Inability or unwillingness to perform self-injection

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Novo Nordisk Investigational Site

    Neuss, 41460

Other trials in Germany

About this study

Official title: A Trial to Demonstrate Bioequivalence Between Semaglutide Formulation D With the DV3396 Pen-injector and Formulation B With the PDS290 Pen-injector in Subjects With Overweight or Obesity

The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the belly using a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject the medicine. Participants will take an injection once a week and will get a total of 21 injections of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 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 they are pregnant, breast-feeding or planning to become pregnant during the study period.

Conditions
Overweight, Obesity
Being tested
Semaglutide
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks

Study groups in NCT04187300
Study groupRoleWhat they receive
DV3396ExperimentalSemaglutide administered with the DV3396 pen-injector (Formulation D)
Receives: Drug: Semaglutide
PDS290ExperimentalSemaglutide administered with the PDS290 pen-injector (Formulation B)
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve

    h*nmol/L

    Measured: 0-168 hours (Day 141-148) after last 2.4 mg dose

  2. Cmax,2.4mg,SS, Maximum observed semaglutide concentration

    nmol/L

    Measured: 0-168 hours (Day 141-148) after last 2.4 mg dose

Secondary outcomes (10)

  1. AUC0-168h,1mg,SS, Area under the semaglutide concentration time curve

    h*nmol/L

    Measured: 0-168 hours (Day 78-85) after last 1 mg dose

  2. Cmax,1mg,SS, Maximum observed semaglutide concentration

    nmol/L

    Measured: 0-168 hours (Day 78-85) after last 1 mg dose

  3. Tmax,2.4mg,SS, Time of maximum observed semaglutide concentration after last 2.4 mg dose

    h

    Measured: 0-168 hours (Day 141-148) after last 2.4 mg dose

  4. Tmax,1mg,SS, Time of maximum observed semaglutide concentration after last 1 mg dose

    h

    Measured: 0-168 hours (Day 78-85) after last 1 mg dose

  5. t½, terminal elimination half-life of semaglutide after last 2.4 mg dose

    h

    Measured: 0-1176 hours (Day 141-190) after last 2.4 mg dose

  6. Cl/F2.4mg, Total apparent clearance of semaglutide after last 2.4 mg dose

    L/h

    Measured: 0-168 hours (Day 141-148) after last 2.4 mg dose

  7. Cl/F1mg, Total apparent clearance of semaglutide after last 1 mg dose

    L/h

    Measured: 0-168 hours (Day 78-85) after last 1 mg dose

  8. Vss/F2.4mg, Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose

    L

    Measured: 0-168 hours (Day 141-148) after last 2.4 mg dose

  9. Vss/F1mg, Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose

    L

    Measured: 0-168 hours (Day 78-85) after last 1 mg dose

  10. Change in body weight

    Measured: From baseline (Day 1, pre-dose) until the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2019
  2. Study start16 Dec 2019
  3. Primary completion23 Sep 2020
  4. Study completion23 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04187300
Sponsor's protocol ID
NN9536-4590
Other IDs
U1111-1236-7697, 2019-002909-21, 2019
Status last verified
Nov 2021
First submitted
3 Dec 2019
Last updated
11 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve (time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04187300.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.

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