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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity & Overweight
• Intervention / Treatment: Drug: Amylin (Pramlintide); Drug: Placebo (NaCl 0.9 % solution); Drug: Pancreatic Polypeptide (PP)

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas H Lange; Phone Number: +4553807019; Email: andreas.holst.lange@rehionh.dk

Study Locations

• Denmark
  • Capital Region
    • Hellerup, Capital Region, Denmark, 2900
      • Recruiting
      • Center for Clinical Metabolic Research, Gentofte Hospital
      • Contact: Andreas H Lange; Phone Number: +4553807019; Email: andreas.holst.lange@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo + Placebo	Drug: Placebo (NaCl 0.9 % solution); This the placebo
Active Comparator: Amylin (Pramlintide) + Placebo	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: Placebo (NaCl 0.9 % solution); This the placebo
Active Comparator: PP + Placebo	Drug: Placebo (NaCl 0.9 % solution); This the placebo; Drug: Pancreatic Polypeptide (PP); This a one of the pancreatic hormones investigated in this study.
Active Comparator: Amylin (Pramlintide) + PP	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food intake	Difference in food intake during an ad libitum meal. Food intake is examined as kalories (kcal) of food eaten during the ad libitum meal.	300 to 330 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite appetite score	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	-30 min to 330
Sensations of hunger, satiety, fullness, prospective food intake, nausea, thirst, comfort	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.	-30 to 330 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Food Intake; Amylin; Pramlintide
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Pharmaceutical Preparations; Pancreatic Hormones; Amyloidogenic Proteins; Amyloid; Solutions; Islet Amyloid Polypeptide; pramlintide; Pancreatic Polypeptide
• Other Study ID Numbers: H-25083528

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No