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NCT Number: NCT03842202

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

semaglutide

Drug

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.

Placebo

Drug

Participants will receive once weekly injections of semaglutide matched placebo.

Primary outcomes

  1. 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)

    Measured in h*micrograms/mL

Secondary outcomes

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

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

    Measured in h*micrograms/mL

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

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

    Measured in micrograms/mL

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

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

    Measured in hours

  4. Energy intake during ad libitum lunch

    Time frame: Day 142

    Measured in kilojoules

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

    Time frame: Day 142

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

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

    Time frame: Day 142

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

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

    Time frame: Day 142

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

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

    Time frame: Day 142

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

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

    Time frame: Day 142

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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