ObesityPhase 1NCT07845578
A Research Study Looking Into How a High Dose of s.c. Semaglutide Works With Emptying of the Stomach in People With Excess Body Weight
A Phase 1 study testing Semaglutide and Paracetamol in people with Obesity and Overweight, run by Novo Nordisk A/S at 1 site in Austria.
Trial summary
The purpose of the study is to determine the effect of semaglutide on gastric emptying in people with obesity. Participants will receive either semaglutide or placebo, and the treatment assigned will be decided by chance. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Semaglutide and Paracetamol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 25 Sep 2026to 11 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Body mass index (BMI) between 30.0 - 44.9 kilogram per meter square (kg/m^2) (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator.
Who cannot join
- Known or suspected hypersensitivity to study intervention(s) (including paracetamol) or related products.
- Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic CYP pathways, such as perikon (St. John's Wort), within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval) and occasional use of paracetamol/acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
- Impaired liver function defined as any of the below:
- Alanine Aminotransferase (ALT) greater than or equal to (>= ) 2.5 times the upper limit of normal (ULN)
- Aspartate Aminotransferase (AST) >=2.5 times ULN
- Total bilirubin greater than (>) 1.5 times ULN
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Investigation of the Effect of High Dose s.c. Semaglutide on Gastric Emptying in Participants With Obesity
The purpose of the study is to determine the effect of semaglutide on gastric emptying in people with obesity. Participants will receive either semaglutide or placebo, and the treatment assigned will be decided by chance. Semaglutide is a medicine that doctors can already prescribe, while placebo contains no active medicine.
- Conditions
- Obesity, Overweight
- Being tested
- Semaglutide, Placebo semaglutide, Paracetamol
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Semaglutide will be administered in the thigh, abdomen, or upper arm of body part.
Placebo semaglutideDrug
Placebo matched to semaglutide will be administered in the thigh, abdomen, or upper arm of body part.
ParacetamolDrug
Paracetamol is administered orally as part of a standardised meal to assess gastric emptying through pharmacokinetic evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Participants will receive semaglutide administered subcutaneously once weekly at multiple dose levels. Receives: Drug: Semaglutide; Drug: Paracetamol |
| Placebo | Placebo comparator | Participants will receive placebo matched semaglutide administered subcutaneously once weekly at multiple dose levels. Receives: Drug: Placebo semaglutide; Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal
Measured in hour micrograms per millilitre (h*µg/mL).
Measured: Day 177
Secondary outcomes (3)
AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal
Measured in h*μg/mL.
Measured: Day 177
Cmax,para; Maximum observed paracetamol plasma concentration following a standardised meal
Measured in microgram per millilitre (μg/mL).
Measured: Day 177
tmax;para: Time to maximum observed paracetamol plasma concentration
Measured in hours.
Measured: Day 177
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start25 Sep 2026 (estimated)
- Primary completion11 Sep 2027 (estimated)
- Study completion11 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845578
- Sponsor's protocol ID
- NN9536-8797
- Other IDs
- U1111-1335-9563, 2026-526083-20
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effect of High Dose s.c. Semaglutide on Gastric Emptying in Participants With Obesity
- ClinicalTrials.gov ID
- NCT07845578
- Acronym / sponsor ID
- NN9536-8797
- Conditions
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 11 Sep 2027 (estimated)
- Study completion
- 11 Sep 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the effect of semaglutide on gastric emptying in people with obesity. Participants will receive either semaglutide or placebo, and the treatment assigned will be decided by chance. Semaglutide is a medicine that doctors can already prescribe, while placebo contains no active medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide, Drug: ParacetamolParticipants will receive semaglutide administered subcutaneously once weekly at multiple dose levels. |
| Placebo | Placebo comparator | Drug: Placebo semaglutide, Drug: ParacetamolParticipants will receive placebo matched semaglutide administered subcutaneously once weekly at multiple dose levels. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Body mass index (BMI) between 30.0 - 44.9 kilogram per meter square (kg/m^2) (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator.
Key exclusion criteria (6 listed)
- Known or suspected hypersensitivity to study intervention(s) (including paracetamol) or related products.
- Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic CYP pathways, such as perikon (St. John's Wort), within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval) and occasional use of paracetamol/acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
- Impaired liver function defined as any of the below:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideSemaglutide will be administered in the thigh, abdomen, or upper arm of body part. | Drug | Semaglutide |
| Placebo semaglutidePlacebo matched to semaglutide will be administered in the thigh, abdomen, or upper arm of body part. | Drug | Placebo |
| ParacetamolParacetamol is administered orally as part of a standardised meal to assess gastric emptying through pharmacokinetic evaluation. | Drug | Placebo, Semaglutide |
Primary outcome
AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal
Time frame: Day 177
Measured in hour micrograms per millilitre (h*µg/mL).
3 secondary outcomes
AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal
Time frame: Day 177
Cmax,para; Maximum observed paracetamol plasma concentration following a standardised meal
Time frame: Day 177
tmax;para: Time to maximum observed paracetamol plasma concentration
Time frame: Day 177
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Semaglutide and Paracetamol in people with Obesity and Overweight, run by Novo Nordisk A/S at 1 site in Austria.
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 6 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: opening soon, as of the sponsor's last update on 29 Sep 2026. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal (time frame: Day 177). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.