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Investigating the Effects of 24 Hour LEAP2 Infusion in Individuals With Overweight and Obesity
Sponsor: University Hospital, Gentofte, Copenhagen
Summary
This study investigates whether temporarily blocking the ghrelin receptor affects appetite and food intake in people with overweight or obesity. Ghrelin is a hormone that stimulates hunger; the researchers are using LEAP2, a naturally occurring hormone that blocks ghrelin's receptor, as a research tool to study what happens when ghrelin signaling is turned off for 24 hours. The study is a randomized, double-blind, placebo-controlled crossover trial. Eighteen adults with overweight or obesity (BMI ≥25 kg/m², elevated body fat percentage) will each complete two 24-hour study visits, at least 7 days apart: one with a continuous LEAP2 infusion and one with a saline placebo infusion, in random order. Neither participants nor most study staff will know which treatment is given on which visit. During each 24-hour visit, participants will receive a standardized liquid test meal followed by ad libitum (eat-until-comfortably-full) lunch, dinner, and breakfast meals, plus access to snacks. The main question the study aims to answer is whether LEAP2 reduces the total amount of food eaten over 24 hours compared to placebo. Additional measurements include blood glucose levels, subjective feelings of hunger and fullness (via questionnaires), stomach emptying rate, blood pressure and heart rate, and hormone levels (including growth hormone, FSH, and LH). Some participants will also undergo a small fat tissue biopsy to study how genes and proteins related to metabolism respond. The results are expected to improve understanding of how ghrelin and LEAP2 regulate appetite and metabolism in people with obesity, which may inform future approaches to treating obesity and related metabolic conditions.
Official title: Investigating the Effects of 24 Hour Ghrelin Receptor Antagonism in Individuals With Overweight and Obesity
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2026-11-30
Completion Date
2027-08-01
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Liver-expressed antimicrobial peptide 2
Continuous intravenous infusion of LEAP2 (Liver-Expressed Antimicrobial Peptide 2), an endogenous inverse agonist and competitive antagonist of the ghrelin receptor (GHSR), administered at 40 pmol/kg/min for 24 hours. LEAP2 inhibits ghrelin-mediated signaling involved in hunger regulation, gastric motility, and growth hormone secretion. This intervention enables investigation of the physiological relevance of ghrelin receptor activity during 24 hours in individuals with overweight or obesity.
Placebo
Continuous intravenous infusion of isotonic saline (0.9% sodium chloride) for 24 hours. This placebo comparator is used to match the volume, rate, and duration of the active intervention (LEAP2) in a randomized, double-blind, crossover design. The placebo enables assessment of the physiological effects of ghrelin receptor blockade by LEAP2 in individuals with overweight or obesity.