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

NCT ID: NCT03842202

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2019-11-04

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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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.

Group Type EXPERIMENTAL

Semaglutide

Intervention Type 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 (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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive once weekly injections of semaglutide matched placebo.

Interventions

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Semaglutide

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.

Intervention Type DRUG

Placebo

Participants will receive once weekly injections of semaglutide matched placebo.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Berlin, , Germany

Site Status

Countries

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Germany

References

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Friedrichsen M, Breitschaft A, Tadayon S, Wizert A, Skovgaard D. The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Diabetes Obes Metab. 2021 Mar;23(3):754-762. doi: 10.1111/dom.14280. Epub 2021 Jan 3.

Reference Type RESULT
PMID: 33269530 (View on PubMed)

Other Identifiers

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U1111-1215-9915

Identifier Type: OTHER

Identifier Source: secondary_id

2018-002497-42

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9536-4455

Identifier Type: -

Identifier Source: org_study_id