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New treatment option for Obesity &Amp; Overweight
Official title Studying the Influence of LEAP2 on Integrated Endocrine Control of Eating During Semaglutide Treatment
ClinicalTrials.gov ID: NCT07171723
What this study is testing
What is Liver-Expressed Antimicrobial Peptide 2 (LEAP2)?
Liver-Expressed Antimicrobial Peptide 2 (LEAP2) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for obesity & overweight.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hellerup, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hellerup, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.