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Trial · Interventional

CompletedPhase 1Registry data

Trial Investigating the Effect of Semaglutide on Energy Intake, Appetite Sensations, Postprandial Glucose and Triglyceride Metabolism and Gastric Emptying in Obese Subjects Compared With Placebo

NCTNCT02079870 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3685Other id2013-000012-24Other idU1111-1138-2039

Overview

Status
Completed
Phase
Phase 1
Enrollment
30 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

United Kingdom

Start
6 Mar 2014
Primary completion
7 Jan 2015
Completion
7 Jan 2015
First posted
6 Mar 2014 (estimated)
Last update posted
2 Dec 2017
Conditions
Diabetes · Metabolism and Nutrition Disorder · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 1

    Trial Investigating the Effect of Semaglutide on Energy Intake, Appetite Sensations, Postprandial Glucose and Triglyceride Metabolism and Gastric Emptying in Obese Subjects Compared With Placebo

    NCT02079870

    6 Mar 2014 to 7 Jan 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • semaglutideDrug
  • placeboDrug

Arms2

  • Experimental

    Sema

    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

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · After 12 weeks of treatment

Secondary outcomes(5)
  1. 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

    Time frame · After 12 weeks of treatment during a standardised meal test day

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

    Time frame · After 12 weeks of treatment during a standardised meal test day

  3. 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)

    Time frame · After 12 weeks of treatment during a standardised meal test day

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

    Time frame · After 12 weeks of treatment during a standardised meal test day

  5. Incidence of adverse events

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2018

11 results

Semaglutide improves postprandial glucose and lipid metabolism, and delays first-hour gastric emptying in subjects with obesity.

Hjerpsted et al. 2018Diabetes, obesity & metabolismcited by 195

PMID 28941314PMC5836914DOI 10.1111/dom.13120PUB-28941314

Free to read · publisher termsCC BY-NC11 results

Indexing hint: Randomized controlled trial · 2017

13 results

Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity.

Blundell et al. 2017Diabetes, obesity & metabolismcited by 539

PMID 28266779PMC5573908DOI 10.1111/dom.12932PUB-28266779

Free to read · publisher termsCC BY-NC-ND13 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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) Exclusion Criteria: * 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

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