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

Sponsor
Novo Nordisk A/S
Study ID
NCT03842202
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 15, 2019
Status verified
Dec 2020
Primary completion
Nov 4, 2019
Completion
Nov 4, 2019

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    Participants will receive increasing doses of semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.
  • Placebo Comparator: Placebo (Semaglutide)
    Participants will receive placebo (semaglutide). The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks

Primary Outcome Measure

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) ]

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