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OverweightPhase 1NCT04012255

A Research Study to Compare Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

A Phase 1 study testing Semaglutide (administered by DV3396 pen) and Semaglutide (administered by PDS290 pen) in people with Overweight and Obesity, run by Novo Nordisk A/S at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. 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 (administered by DV3396 pen) and Semaglutide (administered by PDS290 pen)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesGermany
Study dates
15 Jul 2019to 22 Oct 2019
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

2 sites in 1 country.

Germany2 sites

  • Novo Nordisk Investigational Site

    Mainz, 55116

  • Novo Nordisk Investigational Site

    Neuss, 41460

Other trials in Germany

About this study

Official title: A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations With the DV3396 Pen-injector and 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. 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 stomach with the use of 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 themselves with the medicine. As part of this training participants will self inject placebo (dummy medication) 3 times. Participants will take an injection once a week and will get 21 injections in total 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 (administered by DV3396 pen), Semaglutide (administered by PDS290 pen)
Medical subject headings
Overweight, Obesity

What participants receive

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

  • Semaglutide (administered by DV3396 pen)Drug

    Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 21 weeks

  • Semaglutide (administered by PDS290 pen)Drug

    Increasing doses of semaglutide given sc in the stomach for 21 weeks

Study groups in NCT04012255
Study groupRoleWhat they receive
DV3396ExperimentalParticipants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product)
Receives: Drug: Semaglutide (administered by DV3396 pen)
PDS290Active comparatorParticipants will receive once-weekly doses of semaglutide administered with the PDS290 pen-injector (comparator drug product)
Receives: Drug: Semaglutide (administered by PDS290 pen)

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 following the last administration of semaglutide s.c. 2.4 mg

    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 following the last administration of semaglutide s.c. 2.4 mg

    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 following the last administration of semaglutide s.c. 1 mg

    h*nmol/L

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

  2. Cmax,1mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 1 mg

    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

    percent

    Measured: From baseline (Day 1, pre-dose) until the end of treatment (Day 148)

Timeline

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

  1. First posted9 Jul 2019
  2. Study start15 Jul 2019
  3. Primary completion30 Aug 2019
  4. Study completion22 Oct 2019

Why it stopped: The trial was terminated for strategic reasons.

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04012255
Sponsor's protocol ID
NN9536-4475
Other IDs
U1111-1221-9644, 2018-003923-13, 2018
Status last verified
Oct 2019
First submitted
5 Jul 2019
Last updated
23 Oct 2019
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 (administered by DV3396 pen) and Semaglutide (administered by PDS290 pen) in people with Overweight and Obesity, run by Novo Nordisk A/S at 2 sites 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: stopped early, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 was stopped early (reason given: The trial was terminated for strategic reasons.). Results are not available in the source record.

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 following the last administration of semaglutide s.c. 2.4 mg (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 NCT04012255.

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 23 Oct 2019.

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