Current partner codePEPTIDESDE
NCT07506369·Not applicable·INTERVENTIONAL

Pancreatic Polypeptide as a Modulator of Amylin- Induced Satiety in Healthy Humans

Status

Recruiting

Phase

Not applicable

Enrollment

18

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The two pancreatic hormones amylin and pancreatic polypeptide (PP) has been linked to satiety and energy metabolism. The goal of this this study is to determine the separate and combined effects of the two hormones on food intake and other exploratory endpoints related to metabolism in healthy humans. The aim of this study is to investigate the interaction between the hormones and obtain insight into the physiology of the hormones. The healthy participants will undergo 4 study days in a randomised order receiving the following infusions for 5 hours: A) Amylin + PP B) Amylin + Placebo C) Placebo + PP D) Placebo + Placebo Throughout the day blood samples will be collected and gallbladder motility will be evaluated. Further, indirect calorimetry and heart rate/blood pressure measurement will be performed.

Interventions

Treatment arms and agents.

DRUG

Amylin (Pramlintide)

This a one of the pancreatic hormones investigated in this study. Pramlintide is used a surrogate for amylin due to the fibrillating properties of amylin

DRUG

Pancreatic Polypeptide (PP)

This a one of the pancreatic hormones investigated in this study.

DRUG

Placebo (NaCl 0.9 % solution)

This the placebo

Timeline

From registration to results.

  1. First posted

    Apr 1, 2026

  2. Study start

    Apr 2026

  3. Primary completion

    Oct 2026

  4. Study completion

    Oct 2028

  5. Results posted

    Not reported

  6. Registry updated

    Apr 1, 2026

Outcomes

What the study measures.

Primary outcomes

Food intake

Time frame · 300 to 330 minutes

Difference in food intake during an ad libitum meal. Food intake is examined as kalories (kcal) of food eaten during the ad libitum meal.

Secondary outcomes

Composite appetite score

Time frame · -30 min to 330

A score calculated from visual analog scales of hunger, fullness, and prospective food intake. The visual analog scale goes from 0 to 10 cm = from mimimum to maximum sensation

Sensations of hunger, satiety, fullness, prospective food intake, nausea, thirst, comfort

Time frame · -30 to 330 minutes

The visual analog scale goes from 0 to 10 cm = from mimimum to maximum sensation. One questionnaire includes all the scales and assess all the mentioned sensations.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
MALE
Healthy volunteers
Yes

Inclusion Criteria: * Male * Age between 18 and 65 years at the time of inclusion * Body mass index 18-27 kg/m2 * Fat percentage \< 20% * Informed oral and written consent Exclusion Criteria: * Anaemia (haemoglobin below normal range) * History of hepatobiliary and/or gastrointestinal disorder(s) * Kidney disease * Previous gastric or intestinal resection, cholecystectomy and/or any major intra- abdominal surgery (including bariatric surgery) * Previous pancreatic disease and/or neoplasia * Regular tobacco smoking and/or use of other nicotine products * Glycated haemoglobin (HbA1c) ≥48 and/or type 1 diabetes or type 2 diabetes requiring medical treatment * Initiation of special diets, lifestyle changes and/or weight loss \>5% of total body weight within three months prior to or during study period * Any physical or psychological condition or ongoing medication the investigator group suspects would interfere with trial participation

Study locations

1 registered sites.

Denmark. Showing up to 24 locations stored in the fast local snapshot.

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, Capital Region, Denmark

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.