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OverweightPhase 1NCT03842202

A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With 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

This study will look at how the emptying of the participant's stomach after a meal is affected by semaglutide (a new medicine) compared to a "dummy" medicine. In addition, the study will also look at the effect of semaglutide on the participant's appetite and energy intake. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteGermany
Study dates
15 Feb 2019to 4 Nov 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 between 18 to 65 years (both inclusive) at the time of signing informed consent
  • Body mass index (BMI) between 30.0 and 45.0 kg/m^2 (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
  • Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Novo Nordisk Investigational Site

    Berlin, 14050

Other trials in Germany

About this study

Official title: Effect of Semaglutide 2.4 mg Once-weekly on Gastric Emptying in Subjects With Obesity

This study will look at how the emptying of the participant's stomach after a meal is affected by semaglutide (a new medicine) compared to a "dummy" medicine. In addition, the study will also look at the effect of semaglutide on the participant's appetite and energy intake. Participants will either get semaglutide or "dummy" medicine - which treatment any participant gets is decided by chance. Participants will take 1 injection per week. The study medicine is injected with a thin needle in the stomach, thigh or upper arm. The study will last for about 27 weeks (from first treatment to last check-up). Participants will have 8 visits at the clinic with the study doctor.

Conditions
Overweight, Obesity
Being tested
Semaglutide, Placebo
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

    Participants will receive gradually increasing doses of semaglutide (subcutaneous [s.c.], in the thigh, abdomen or upper arm) injection once weekly, until they reach a dose of level of 2.4 mg, which they will continue for 5 weeks.

  • PlaceboDrug

    Participants will receive once weekly injections of semaglutide matched placebo.

Study groups in NCT03842202
Study groupRoleWhat they receive
SemaglutideExperimentalParticipants will receive increasing doses of semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.
Receives: Drug: Semaglutide
Placebo (Semaglutide)Placebo comparatorParticipants will receive placebo (semaglutide). The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks
Receives: Drug: Placebo

What is being measured

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

  1. AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state

    Measured in h*micrograms/mL

    Measured: 0 to 5 hours after standardised meal (day 142)

Secondary outcomes (9)

  1. AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state

    Measured in h*micrograms/mL

    Measured: 0 to 1 hour after standardised meal (day 142)

  2. Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours

    Measured in micrograms/mL

    Measured: 0 to 5 hours after standardised meal (day 142)

  3. Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours

    Measured in hours

    Measured: 0 to 5 hours after standardised meal (day 142)

  4. Energy intake during ad libitum lunch

    Measured in kilojoules

    Measured: Day 142

  5. Mean postprandial rating - Hunger (AUC30-300min/270 min) using visual analogue scales (VAS) from 30 up to 300 minutes during standardised breakfast meal

    Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.

    Measured: Day 142

  6. Mean postprandial rating - Fullness (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal

    Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.

    Measured: Day 142

  7. Mean postprandial rating - Satiety (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal

    Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.

    Measured: Day 142

  8. Mean postprandial rating - Prospective food consumption (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal

    Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.

    Measured: Day 142

  9. Mean postprandial rating - Overall appetite score (OAS) (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal

    Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.

    Measured: Day 142

Timeline

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

  1. First posted15 Feb 2019
  2. Study start15 Feb 2019
  3. Primary completion4 Nov 2019
  4. Study completion4 Nov 2019

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03842202
Sponsor's protocol ID
NN9536-4455
Other IDs
U1111-1215-9915, 2018-002497-42, 2018
Status last verified
Dec 2020
First submitted
13 Feb 2019
Last updated
24 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Friedrichsen M, Breitschaft A, Tadayon S, Wizert A, Skovgaard D. The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Diabetes Obes Metab. 2021 Mar;23(3):754-762. doi: 10.1111/dom.14280. Epub 2021 Jan 3.

    PubMed 33269530

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 2 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 24 Dec 2020. 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. Some participants in this study may receive a placebo. 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?

AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state (time frame: 0 to 5 hours after standardised meal (day 142)). 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 NCT03842202, which also lists 1 linked publication.

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 24 Dec 2020.

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