Obesity & OverweightAPPNCT07506369
Pancreatic Polypeptide as a Modulator of Amylin- Induced Satiety in Healthy Humans
A study testing Amylin (Pramlintide) and Pancreatic Polypeptide (PP) in people with Obesity & Overweight, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Amylin (Pramlintide) and Pancreatic Polypeptide (PP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Capital Region, 2900
Andreas H Lange, +4553807019, andreas.holst.lange@regionh.dk
About this study
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:
- 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.
- Conditions
- Obesity & Overweight
- Being tested
- Amylin (Pramlintide), Pancreatic Polypeptide (PP), Placebo (NaCl 0.9 % solution)
- Keywords
- Amylin, Pramlintide, Food Intake
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Amylin (Pramlintide) + Placebo | Active comparator | Not described Receives: Drug: Amylin (Pramlintide); Drug: Placebo (NaCl 0.9 % solution) |
| PP + Placebo | Active comparator | Not described Receives: Drug: Pancreatic Polypeptide (PP); Drug: Placebo (NaCl 0.9 % solution) |
| Amylin (Pramlintide) + PP | Active comparator | Not described Receives: Drug: Amylin (Pramlintide); Drug: Pancreatic Polypeptide (PP) |
| Placebo + Placebo | Placebo comparator | Not described Receives: Drug: Placebo (NaCl 0.9 % solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 300 to 330 minutes
Secondary outcomes (2)
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
Measured: -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.
Measured: -30 to 330 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asger Lund, MD, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506369
- Sponsor's protocol ID
- H-25083528
- Acronym
- APP
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Polypeptide as a Modulator of Amylin- Induced Satiety in Healthy Humans
- ClinicalTrials.gov ID
- NCT07506369
- Acronym / sponsor ID
- APP / H-25083528
- Conditions
- Obesity & Overweight
- Keywords
- Amylin, Pramlintide, Food Intake
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Amylin (Pramlintide) + PP, Amylin (Pramlintide) + Placebo |
| Pancreatic Polypeptide (PP)This a one of the pancreatic hormones investigated in this study. | Drug | Amylin (Pramlintide) + PP, PP + Placebo |
| Placebo (NaCl 0.9 % solution)This the placebo | Drug | Amylin (Pramlintide) + Placebo, PP + Placebo, Placebo + Placebo |
Primary outcome
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.
2 secondary outcomes
Composite appetite score
Time frame: -30 min to 330
Sensations of hunger, satiety, fullness, prospective food intake, nausea, thirst, comfort
Time frame: -30 to 330 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amylin (Pramlintide) and Pancreatic Polypeptide (PP) in people with Obesity & Overweight, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas H Lange (+4553807019, andreas.holst.lange@rehionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food intake (time frame: 300 to 330 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.