Actively Recruiting
Studying the Influence of LEAP2 on Integrated Endocrine Control of Eating During Semaglutide Treatment
Led by University Hospital, Gentofte, Copenhagen · Updated on 2025-09-18
24
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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). LEAP2, a naturally occurring hormone that inhibits the ghrelin receptor, is used as the investigational compound. The objective of the study is to clarify how the ghrelin system functions when appetite is suppressed by semaglutide treatment. Participants will receive either LEAP2 or placebo during two experimental visits in a randomized, double-blind, crossover design. The investigators will assess food intake, appetite sensations, glucose metabolism, and hormonal responses. By examining the interaction between semaglutide and ghrelin signaling, the study aims to improve understanding of how multiple appetite-regulating systems interact and whether additional hunger signals remain active during GLP-1 treatment. The findings may inform the development of future treatments for individuals with obesity.
CONDITIONS
Official Title
Studying the Influence of LEAP2 on Integrated Endocrine Control of Eating During Semaglutide Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old
- Body mass index (BMI) above 125 kg/m2
- Stable semaglutide treatment with a dose of 11 mg once weekly for at least 3 months before joining
- Weight stable within plus or minus 3% during the 3 months before joining
- Provided informed oral and written consent
You will not qualify if you...
- Anaemia
- Alanine aminotransferase (ALAT) above 2 times the normal value
- History of liver or gastrointestinal disorders
- Kidney disease shown by high serum creatinine or urine albumin-creatinine ratio above 30 mg/g confirmed twice
- Taking medications that may interfere with study participation as judged by investigators
- Any physical or psychological condition that may interfere with participation including acute or chronic illness
- Regular tobacco smoking or use of nicotine products
- Glycated haemoglobin HbA1c above 48 or treatment for type 1 or type 2 diabetes
- Women who can become pregnant but are not using effective contraception
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Denmark, 2900
Actively Recruiting
Research Team
C
Christian Legart, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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