NCT02079870

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the effect of semaglutide on energy intake, appetite sensations, postprandial glucose and triglyceride metabolism and gastric emptying in obese subjects compared with placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Mar 2014

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

March 6, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2015

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

March 4, 2014

Last Update Submit

November 30, 2017

Conditions

DiabetesMetabolism and Nutrition DisorderObesity

Outcome Measures

Primary Outcomes (1)

  • Ad libitum energy intake during a lunch meal (following a standardised breakfast meal)

    After 12 weeks of treatment

Secondary Outcomes (5)

  • Mean postprandial increase (iAUC30-300min/270 min) in rating of overall appetite score (OAS) using Visual Analogue Scales (VAS) before and up to 300 minutes after intake of a standardised breakfast meal

    After 12 weeks of treatment during a standardised meal test day

  • Incremental area under the 0-300 minutes glucose profile (iAUC0-300min,Glucose) following intake of a standardised breakfast meal

    After 12 weeks of treatment during a standardised meal test day

  • Gastric emptying measured by the area under the 0-300 minutes plasma paracetamol concentration curve (AUC0-300min,para) following intake of a standardised breakfast meal (including 1500 mg paracetamol)

    After 12 weeks of treatment during a standardised meal test day

  • Incremental area under the 0-480 minutes triglyceride profile (iAUC0-480min,TG) following intake of a standardised fat-rich meal

    After 12 weeks of treatment during a standardised meal test day

  • Incidence of adverse events

    From baseline to follow-up (5-7 weeks after last trial drug administration)

Study Arms (2)

Sema

EXPERIMENTAL

Two 12-week treatment periods separated by a wash-out period of 5-7 weeks. Finally, a follow-up visit is performed 5-7 weeks after last dosing

Drug: semaglutide

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

semaglutideDRUG

Solution for subcutaneous (s.c. - under the skin) injection. 0.25 mg semaglutide once weekly for four weeks, 0.5 mg semaglutide once weekly for four weeks followed by 1.0 mg semaglutide once weekly for five weeks

Sema
placeboDRUG

Solution for subcutaneous (s.c. - under the skin) injection

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age above or equal to 18 years at the time of signing informed consent
  • HbA1c (glycosylated haemoglobin A1c) below 6.5%
  • A BMI (body mass index) between 30-45 kg/m\^2 (both inclusive)

You may not qualify if:

  • Females who are pregnant, breast-feeding or intend to become pregnant or is of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local law or practice, UK requirements: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods together with the use of spermicide, and sexual abstinence)
  • Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
  • Diagnosis of type 1 or 2 diabetes mellitus
  • Anticipated change in lifestyle (e.g. eating, exercise or sleeping pattern) during the trial
  • Use of any prescription or non-prescription medication which could interfere with trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or specifically: 1) within 12 months prior to screening any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers, 2) within 3 months prior to screening use of statins, antihyperlipidemics including fibrates or nicotinic acid and its derivates, 3) supplementation with omega 3 fatty acids from 1 month prior to screening, 4) co-treatment with antihypertensive drugs is allowed if treatment has been stable for at least 1 month prior to screening and treatment should be kept unchanged during the trial
  • Significant history of alcoholism or drug/chemical abuse within 1 year from screening, or a positive result of the urine drug screen or alcohol breath test, or consuming more than 21 units of alcohol per week for females and 28 units of alcohol per week for males (1 unit of alcohol equals ½ pint \[285 mL\] of beer or lager, 1 glass \[125 mL\] of wine, or 1/6 gill \[25 mL\] of spirits)
  • Smoking or use of any nicotine products (including nicotine patches, gum etc.) in the last 3 months prior to screening or a positive cotinine test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Leeds, LS2 9LH, United Kingdom

Location

Related Publications (2)

  • Blundell J, Finlayson G, Axelsen M, Flint A, Gibbons C, Kvist T, Hjerpsted JB. Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity. Diabetes Obes Metab. 2017 Sep;19(9):1242-1251. doi: 10.1111/dom.12932. Epub 2017 May 5.

    PMID: 28266779RESULT

  • Hjerpsted JB, Flint A, Brooks A, Axelsen MB, Kvist T, Blundell J. Semaglutide improves postprandial glucose and lipid metabolism, and delays first-hour gastric emptying in subjects with obesity. Diabetes Obes Metab. 2018 Mar;20(3):610-619. doi: 10.1111/dom.13120. Epub 2017 Oct 27.

    PMID: 28941314RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusNutrition DisordersObesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

March 6, 2014

Primary Completion

January 7, 2015

Study Completion

January 7, 2015

Last Updated

December 2, 2017

Record last verified: 2017-11

Locations

GB(1)