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

NCT07845578 | Not Yet Recruiting Phase 1

• 3 other identifiers: NN9536-8797U1111-1335-95632026-526083-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Overweight

Outcome Measures

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).

  Day 177

Secondary Outcomes (3)

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

  Day 177

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

  Day 177

• tmax;para: Time to maximum observed paracetamol plasma concentration

  Day 177

Study Arms (2)

Semaglutide

EXPERIMENTAL

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

Drug: Semaglutide; Drug: Paracetamol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo semaglutide; Drug: Paracetamol

Interventions

Semaglutide DRUG

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

Semaglutide

Placebo semaglutide DRUG

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

Placebo

Paracetamol DRUG

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

Placebo; Semaglutide

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

semaglutide; Acetaminophen

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: September 25, 2026
• Primary Completion (Estimated): September 11, 2027
• Study Completion (Estimated): September 11, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)