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NCT Number: NCT07506369

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

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.

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Key information

Conditions

Obesity & Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, Capital Region, 2900, Denmark

Location status: Recruiting

Location contact

Andreas H Lange

CONTACT

[email protected]

+4553807019

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amylin (Pramlintide)

Drug

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

Pancreatic Polypeptide (PP)

Drug

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

Placebo (NaCl 0.9 % solution)

Drug

This the placebo

Primary outcomes

  1. 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

  1. 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

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas H Lange

CONTACT

[email protected]

+4553807019

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Acronym: APP

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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