Status:
RECRUITING
Studying the Influence of LEAP2 on Integrated Endocrine Control of Eating During Semaglutide Treatment
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Obesity &Amp; Overweight
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This clinical study investigates how blocking the hunger-related ghrelin receptor affects appetite and metabolism in individuals with obesity who are treated with semaglutide (a GLP-1 receptor agonist...
Detailed Description
This study investigates the physiological role of ghrelin receptor signaling in individuals with obesity receiving stable treatment with semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years old
- Body mass index (BMI) above ≥ 25 kg/m2
- Ongoing semaglutide treatment with a stable dose of ≥ 1 mg once weekly for a minimum of 3 months prior to inclusion
- Weight stability, defined as a maximum variation of ±3% between the highest and lowest recorded body weight during the 3 months prior to inclusion.
- Informed oral and written consent
Exclusion
- Anaemia
- Alanine aminotransferase (ALAT) \> 2 times normal value
- History of hepatobiliary and/or gastrointestinal disorder
- Kidney disease (serum creatinine above normal range and/or urine albumin-creatinine ratio 30mg/g confirmed with two measurements)
- Any ongoing medication that investigator evaluates would interfere with study participation
- Any physical or psychological condition that investigators evaluate would interfere with study participation including any acute or chronic illnesses.
- Regular tobacco smoking and/or use of other nicotine products
- Glycated haemoglobin HbA1c \> 48 and/or type 1 or type 2 diabetes medical treatment
- Women of childbearing potential who are not using effective contraception
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07171723
Start Date
September 1 2025
End Date
February 1 2026
Last Update
September 18 2025
Active Locations (1)
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1
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Denmark, 2900