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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorNovo Nordisk A/S

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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/m²) (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator.

Disqualifiers

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.

Alanine Aminotransferase (ALT) greater than or equal to (>= ) 2.5 times the upper limit of normal (ULN)

Aspartate Aminotransferase (AST) >=2.5 times ULN

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semaglutide

    Drug

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

  • Placebo semaglutide

    Drug

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

  • Paracetamol

    Drug

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SemaglutideExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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