NCT07171723 Studying the Influence of LEAP2 on Integrated Endocrine Control of Eating During Semaglutide Treatment
| NCT ID | NCT07171723 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Hospital, Gentofte, Copenhagen |
| Condition | Obesity &Amp; Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2025-12-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-09-01 with a primary completion date of 2025-12-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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). 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07171723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity &Amp; Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07171723 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07171723 currently recruiting?
Yes, NCT07171723 is actively recruiting participants. Contact the research team at christian.legart.01@regionh.dk for enrollment information.
Where is the NCT07171723 trial being conducted?
This trial is being conducted at Hellerup, Denmark.
Who is sponsoring the NCT07171723 clinical trial?
NCT07171723 is sponsored by University Hospital, Gentofte, Copenhagen. The trial plans to enroll 24 participants.
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