NCT06845033

Brief Summary

The naturally occurring peptide hormone liver-expressed antimicrobial peptide 2 (LEAP2) in an antagonist/inverse agonist towards the ghrelin receptor. Ghrelin administration has previously been shown to increase food cue reactivity in brain regions related to appetite and reward using functional MRI scans. The aim of this clinical study is to investigate the effects of LEAP2 infusion on food cue reactivity in brain regions related to appetite and reward. Since LEAP2 is an antagonist/inverse agonist towards the ghrelin receptor we hypothesize, that LEAP2 infusion will decrease food cue reactivity in the above-mentioned regions compared to placebo infusion. Participants with obesity (BMI 30-50 kg/m2) will be included and complete two experimental days with either LEAP2 or placebo infusion in a randomized crossover manner. On experimental days, participants will undergo a MRI scan with functional and anatomical modalities. The study will attribute to gain a deeper understanding of the ghrelin system and its interaction with appetite regulation.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
May 2025Nov 2027

First Submitted

Initial submission to the registry

February 7, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2026

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Expected
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

February 7, 2025

Last Update Submit

April 28, 2026

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (1)

  • Difference in food cue reactivity between experimental days

    The primary endpoint is the change in BOLD signals when viewing pictures of food vs. non-food. Differences will be compared between the two experimental days with infusion of placebo and LEAP2, respectively.

    time 75 - 135 minutes

Secondary Outcomes (2)

  • Difference in appetite ratings

    From baseline to end of infusion

  • Changes in peptide hormone concentrations

    From baseline to end of infusion

Other Outcomes (2)

  • Reactivity from Negative Emoition Reactivity Test (NERT)

    time 75 - 135 minutes

  • Plasma glucose

    Through experimental day. From timepoints -15 to 135 min

Study Arms (2)

LEAP2 infusion

ACTIVE COMPARATOR
Other: LEAP2 infusion

Placebo infusion

PLACEBO COMPARATOR
Other: Placebo

Interventions

LEAP2 infusionOTHER

The LEAP2 infusion is a hormone infusion that is different from the placebo (saline) infusion

LEAP2 infusion
PlaceboOTHER

Placebo infusion (saline) is different from the LEAP2 infusion

Placebo infusion

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index 30-50 kg/m2
  • Men
  • Informed consent

You may not qualify if:

  • Anaemia (haemoglobin below normal range)
  • Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \>2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s)
  • Nephropathy (serum creatinine above normal range and/or albuminuria)
  • Glycated haemoglobin (HbA1c) ≥48 mmol/mol and/or type 2 diabetes requiring medical treatment
  • Regular tobacco smoking or use of other nicotine-containing products
  • Claustrophobia
  • Any ongoing medication that the investigator evaluates would interfere with trial participation.
  • Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Metabolic Research

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 25, 2025

Study Start

May 1, 2025

Primary Completion

March 3, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

DK(1)