Studying the Influence of LEAP2 on Integrated Endocrine Control of Eating During Semaglutide Treatment
Recruiting · NCT07171723 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Gentofte, Copenhagen
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Center for Clinical Metabolic Research, Gentofte Hospital - Hellerup, Denmark