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Not yet recruitingNCT07845578Updated Sep 29, 2026

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 interventional study of Semaglutide and Placebo semaglutide in Obesity and Overweight, sponsored by Novo Nordisk A/S. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

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

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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. Semaglutide is a medicine that doctors can already prescribe, while placebo contains no active medicine.

02

Conditions studied

  • Obesity
  • Overweight
03

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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:

    1. Alanine Aminotransferase (ALT) greater than or equal to (>= ) 2.5 times the upper limit of normal (ULN)
    2. Aspartate Aminotransferase (AST) >=2.5 times ULN
    3. Total bilirubin greater than (>) 1.5 times ULN
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Semaglutide

    Participants will receive semaglutide administered subcutaneously once weekly at multiple dose levels.

    Drug: Semaglutide · Drug: Paracetamol

  • Placebo comparator
    Placebo

    Participants will receive placebo matched semaglutide administered subcutaneously once weekly at multiple dose levels.

    Drug: Placebo semaglutide · Drug: Paracetamol

Interventions

  • DrugSemaglutide

    Semaglutide will be administered in the thigh, abdomen, or upper arm of body part.

  • DrugPlacebo semaglutide

    Placebo matched to semaglutide will be administered in the thigh, abdomen, or upper arm of body part.

  • DrugParacetamol

    Paracetamol is administered orally as part of a standardised meal to assess gastric emptying through pharmacokinetic evaluation.

05

What researchers measure

Primary outcomes

  1. AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal

    Measured in hour micrograms per millilitre (h\*µg/mL).

    Time frame: Day 177

Secondary outcomes

  1. AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal

    Measured in h\*μg/mL.

    Time frame: Day 177

  2. Cmax,para; Maximum observed paracetamol plasma concentration following a standardised meal

    Measured in microgram per millilitre (μg/mL).

    Time frame: Day 177

  3. tmax;para: Time to maximum observed paracetamol plasma concentration

    Measured in hours.

    Time frame: Day 177

06

Study locations

1 site
  • Medical University of Graz
    Graz, 8010, Austria
07

References and documents

Individual participant data

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

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07845578
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Sep 25, 2026 (estimated)
Primary completion
Sep 11, 2027 (estimated)
Completion
Sep 11, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency (dept. 2834)
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 ↗

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