Fasting Effects with GLP-1 Medications for Obesity
Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medications Affect the Amount of Food Left in the Stomach in People Using Liraglutide (Injected), Semaglutide (Taken by Mouth) or Semaglutide (Injected)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
71 (estimated)
Sponsor
Novo Nordisk A/S · Industry
Who this trial is looking for
This trial is looking for adults who use GLP-1 medications like liraglutide or semaglutide and want to understand how fasting affects food in the stomach. Participants will be involved in assessments related to their medication and eating habits.
Are You a Good Fit for This Trial?
Must be takingMetformin
Rules you outType 1 diabetes
You may be able to join if
I am 18 years or older.
I have a BMI between 25.0 and 45.0.
I have been using liraglutide or semaglutide.
I have type 2 diabetes diagnosed for more than 180 days.
I am taking either no antidiabetic drugs or a stable dose of metformin.
You may not be able to join if
I have significant gastrointestinal disorders.
I have had major surgery on my stomach in the past.
I have gastroparesis or severe reflux disease with daily symptoms.
I cannot lie on my right side for an ultrasound.
I have unusual meal habits or special diet restrictions.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to investigate how the duration of fasting and temporary stopping of Glucagon-Like-Peptide 1 (GLP-1) medications affect the amount of food left in the stomach in people using liraglutide (injected), semaglutide (taken by mouth) or semaglutide (injected). The length of participants participation in the study will depend on the type of GLP-1 RA treatment participants are…
The purpose of this study is to investigate how the duration of fasting and temporary stopping of Glucagon-Like-Peptide 1 (GLP-1) medications affect the amount of food left in the stomach in people using liraglutide (injected), semaglutide (taken by mouth) or semaglutide (injected). The length of participants participation in the study will depend on the type of GLP-1 RA treatment participants are already using.
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* Male or female.
* Age 18 years or above at the time of signing the informed consent.
* BMI between 25.0 and 45 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
For participants…
Inclusion Criteria:
* Male or female.
* Age 18 years or above at the time of signing the informed consent.
* BMI between 25.0 and 45 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
For participants with T2D:
* Diagnosed with type 2 diabetes (T2D) more than (\>) 180 days before screening.
* Treatment with:
1. no antidiabetic drugs or
2. stable metformin dose or both \[stable dose is defined as the maximum daily tolerated dose for more than or equal to (≥) 90 days before screening\]
Exclusion Criteria:
* Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
* History of major surgical procedures involving the oesophagus or stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
* Diagnosed with or suspected to suffer from clinically significant gastroparesis, hiatal hernia or severe gastro-oesophageal reflux diseases with daily symptoms and/or in supine position.
* Use of other medications known to affect the motility of the stomach.
* Inability to lie in the right lateral decubitus position for gastric ultrasonography.
* Unusual meal habits and special diet requirements or unwillingness to eat the meals provided in the study.
For participants without T2D:
\- Glycosylated hemoglobin (HbA1c) \> 6.5 percent (%) 48 millimole per mole (mmol/mol) at screening.
For participants with T2D:
* HbA1c ≥ 10.5 % (91 mmol/mol) at screening.
* Current treatment with insulin or insulin secretagogues that might increase risk of hypoglycaemia during periods of fasting.
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within 180 days before screening
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