Effects of Antagonizing the Ghrelin Receptor in Individuals With Obesity on Treatment With Semaglutide

Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Center for Clinical Metabolic Research, Gentofte Hospital
RECRUITING
Hellerup
Contact Information
Primary
Christian Legart, MD
christian.legart.01@regionh.dk
+4520891501
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 24
Treatments
Experimental: LEAP2
An intravenous infusion of LEAP2, an endogenous inverse agonist and competitive antagonist of the ghrelin receptor (GHSR), will be administered at 40 pmol/kg/min for 6 hours.
Placebo_comparator: Placebo
An intravenous infusion of isotonic saline (placebo) will be administered for 6 hours
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Gentofte, Copenhagen

This content was sourced from clinicaltrials.gov