NCT07506369

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
28mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Oct 2028

First Submitted

Initial submission to the registry

March 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 24, 2026

Last Update Submit

March 27, 2026

Conditions

Obesity & Overweight

Keywords

AmylinPramlintideFood Intake

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Composite appetite score

    -30 min to 330

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

    -30 to 330 minutes

Study Arms (4)

Amylin (Pramlintide) + Placebo

ACTIVE COMPARATOR
Drug: Amylin (Pramlintide)Drug: Placebo (NaCl 0.9 % solution)

PP + Placebo

ACTIVE COMPARATOR
Drug: Pancreatic Polypeptide (PP)Drug: Placebo (NaCl 0.9 % solution)

Amylin (Pramlintide) + PP

ACTIVE COMPARATOR
Drug: Amylin (Pramlintide)Drug: Pancreatic Polypeptide (PP)

Placebo + Placebo

PLACEBO COMPARATOR
Drug: Placebo (NaCl 0.9 % solution)

Interventions

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

Amylin (Pramlintide) + PPAmylin (Pramlintide) + Placebo
Pancreatic Polypeptide (PP)DRUG

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

Amylin (Pramlintide) + PPPP + Placebo
Placebo (NaCl 0.9 % solution)DRUG

This the placebo

Amylin (Pramlintide) + PlaceboPP + PlaceboPlacebo + Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Body mass index 18-27 kg/m2
  • Fat percentage \< 20%
  • Informed oral and written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, Capital Region, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Interventions

Islet Amyloid PolypeptidepramlintidePancreatic PolypeptideSolutions

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsAmyloidogenic ProteinsAmyloidProteinsNeuropeptidesNerve Tissue ProteinsPharmaceutical Preparations

Central Study Contacts

Andreas H Lange

CONTACT

+4553807019andreas.holst.lange@rehionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Center for Clinical Metabolic Research

Study Record Dates

First Submitted

March 24, 2026

First Posted

April 1, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2028

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

DK(1)