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SILENCED

RecruitingPhase 1, PHASE2

Studying the Influence of LEAP2 on Integrated Endocrine Control of Eating During Semaglutide Treatment

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

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

24

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥25

Primary endpoint

Food intake

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07171723
Org study IDH-25035700

Timeline

Milestones

Study start2025-09-01actual
Study first posted2025-09-12actual
Last update posted2025-09-18actual
Primary completion2025-12-14estimated
Study completion2026-02-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
6
Cardiometabolic biomarkers
4
Patient-reported / QoL
2
Safety / tolerability / PK
2
Glycemic / diabetes
1
Other clinical outcomes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Plasma concentrations of glucose

Time frame:-30 to 290 minutes

Postprandial glucose

descriptive

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Circulating levels of acyl-ghrelin

Time frame:-30 to 290 minutes

concentration, descriptive

Other/protocol endpoint/low confidence

Lipids and other metabolism markers

Time frame:-30 to 290 minutes

descriptive

Other/protocol endpoint

Systolic and diastolic blood pressure

Time frame:-30 to 290 minutes

descriptive, improvement

Other/protocol endpoint

Heart rate

Time frame:-30 to 290 minutes

Heart rate, change

descriptive

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint/low confidence

Composite score of sensation of hunger, fullness (reverse corded) and prospective food intake.

Time frame:-30 to 290 minutes

descriptive

Other/protocol endpoint

Sensation of nausea, thirst, and comfort

Time frame:-30 to 290 minutes

PGI, change

descriptive, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Gastric emptying

Time frame:-30 to 290 minutes

concentration, descriptive

Other/protocol endpoint

Gallbladder motility

Time frame:290 to 310 minutes

Gallbladder event

descriptive

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Food intake

Time frame:290 to 310 minutes

descriptive

Other (unclassified)

6 endpoints
Secondary/protocol endpoint/low confidence

Circulating levels of growth hormone and IGF-1

Time frame:-30 to 290 minutes

concentration, descriptive

Other/protocol endpoint/low confidence

Circulating levels of LEAP2, insulin, glucagon, and other hormones and signaling molecules regulating glucose metabolism, gastrointestinal motility, energy expenditure and eating behaviour

Time frame:-30 to 290 minutes

concentration, descriptive

Other/protocol endpoint/low confidence

Energy expenditure

Time frame:-30 to 290 minutes

descriptive

Other/protocol endpoint/low confidence

Duration of ad libitum meal

Time frame:290 to 310 minutes

descriptive

Other/protocol endpoint/low confidence

Water intake during ad libitum meal

Time frame:290 minutes to 310 minutes

descriptive

Other/protocol endpoint/low confidence

Water intake during ad libitum meal

Time frame:290 to 310 minutes

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.