ObesityPhase 2/3TOTTNCT06619015
Tailoring Obesity Treatment Trial
A Phase 2/3 study testing Pramlintide Acetate 1 MG/ML, Semaglutide Pen Injector and Sodium Chloride 0.9% Inj in people with Obesity and Appetite Regulation, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
The two main aims of this clinical study is; 1. To investigate if the results from a series of physiological tests and questionnaires prior to treatment, can be used to predict the treatment response to obesity medication 2. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Appetite Regulation, PreDiabetes
- What is being tested?
- Pramlintide Acetate 1 MG/ML, Semaglutide Pen Injector and Sodium Chloride 0.9% Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2025to 1 Apr 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≧ 30kg/m2
- HbA1c 39-47 mmol/mol (pre-diabetes)
- Male or female
- Aged >18 years of age and <70 years
- Negative pregnancy test, and willing to use contraceptives during the study period
Who cannot join
- Presence of diabetes with or without treatment
- Current or recent (<6 months) treatment with GLP1 RA's
- Previous gastrointestinal surgery that might affect gastric emptying, nutritional absorption and postprandial GI peptide production
- History of acute or chronic pancreatitis
- Chronic kidney disease
- Use of any antipsychotic drugs
Show all 11Show fewer
- Use of any antiresorptive or bone-anabolic drugs or fractures within < 6 months
- Use of systemic oral glucocorticoids within < 6 months
- Newly (< 3 months) initiated hormonal contraceptive or other hormone therapy
- Recent (<3 months) weight loss ≧ 1% of body weight
- Presence of Binge eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Pramlintide on Top of Semaglutide in Obese People With Prediabetes
The two main aims of this clinical study is;
- To investigate if the results from a series of physiological tests and questionnaires prior to treatment, can be used to predict the treatment response to obesity medication
- To investigate the effect of combining semaglutide and pramlintide on various aspects of appetite, food preference and eating habits.
Read more
The study is planed as a 26 week, double blinded, randomized, placebo controlled trial. The goal is to include N=40. They will all receive weekly semaglutide injections. After 24 weeks they will be randomized to receive either an amylin analog (pramlintide) or placebo as a continuous infusion for two weeks, in addition to weekly semaglutide.
The results from this study will contribute to identifying possible predictors of treatment response, enabling optimal individualized medical weight loss treatment. As well as providing knowledge on the complex interplay between incretin hormones and their effects on appetite and eating habits.
Read the detailed description
Obesity is a major global health challenge and the prevalence of obesity is increasing. Presence of obesity increases the risk of several diseases, physical limitations and an increased mortality. When weightloss is wanted in order to avoid or treat some of these diseases, medical weight loss treatment is one of the options. Among these modified gut hormones, such as Glucagon Like Peptide -1 Receptor agonists (GLP-1RA). However, the individual response to GLP-1RA treatments varies considerably. Currently the best predictor of total weight loss is achieved weight loss after three months of treatment. With more pharmaceutical options to come, a trial and error approach is not appropriate. There is a need to identify possible pre-treatment predictors to treatment response.
This is one of the project\'s main aims. By being able to predict the treatment response, one can tailor the obesity treatment to the individual improving the treatment outcome.
Amylin is co-secreted with insulin from the pancreas in response to meals. It is found to have many similar effects in the body as GLP-1. However their combination, especially on appetite, food preferences and eating pattern is sparsely investigated. This is the other main aim of the project.
This clinical study will be a 26 week, randomized, double-blinded, placebo-controlled trial. Forty overweight (BMI ≥30kg/m2) individuals with pre-diabetes (HbA1c 39-47 mmol/mol) will all receive once-weekly semaglutide for 26 weeks. Semaglutide will be given in escalating doses aiming to reach the maximal dose of 2.4 mg (maximum dosage approved for treatment of overweight), but accepting lower maximal tolerable dosage.
After 24 weeks of treatment, they will be stratified according to their weight loss (\&lt;15% or ≧15%) and based on this stratification, block randomized 1:1 to receive either pramlintide or placebo(normal isotonic 0.9% saline solution) in addition to weekly semaglutide. Pramlintide will be continuously infused, starting at a dosage of 7,5 mcg/hour for three days, and if tolerated, the dosage will be increased to 15 mcg/hour for the remaining eleven days. Previous studies have found measurable changes in appetite after a single dosage of pramlintide, and measurable weight loss after two weeks of treatment. For the continuous infusion a commercially available insulin pump will be used.
At study start and, prior to semaglutide treatment, body composition, REE and gastric emptying rate will be measured. Various aspects of appetite will be assessed by the results from the meal tests, the "taste test", appetite assessment and eating related questionnaires. An appetite Visual Analog Scale (VAS) will be measured prior to, and following the standardized meal test and the ad libitum meal test. Satiety will be assessed by a VAS following the standardized meal test. Appetite related sensory specific desire will be assessed by the participants rating of a "taste test" consisting of a variety of small food samples representing the sensory profiles of sweet, sour, salt, bitter, fat, umami/savory and spicy, respectively. The "taste test" will be performed prior to the ad libitum test and as previously described. And satiation will be assessed by measuring calories consumed to reach fullness and terminate the meal at the ad libitum meal test. While the Food pleasure scale, Yale Food Addiction Scale 2.0, Dutch Eating Behavior Questionnaire and The Eating Disorder Quality of Life Scale questionnaires will assess hedonic, emotional and binge- eating patterns and eating related quality of life. The combined results of these physical measurements, questionnaires, appetite and hunger assessments will be used to identify the participants\&#39; main obesity driver or obesity "phenotype" similarly as previously described.
These tests will be repeated at the end of the study and the results compared. The "taste test" and ad libitum meal test will also be performed after 24 weeks, prior to the addition of either pramlintide or placebo.
Additionally blood samples will be taken at baseline, after 24 weeks and at the end of the study, measuring biomarkers related to metabolism, bone metabolism and organ specific biomarkers.
- Conditions
- Obesity, Appetite Regulation, PreDiabetes
- Being tested
- Pramlintide Acetate 1 MG/ML, Semaglutide Pen Injector, Sodium Chloride 0.9% Inj
- Keywords
- semaglutide, pramlintide, symlin, placebo, obesity, individualized medicine, tailoring treatment, Anti-Obesity Drugs, Appetite Regulation, Treatment Effect Heterogeneity, PreDiabetes
- Medical subject headings
- Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramlintide Acetate 1 MG/MLDrug
Also called Symlin
Symlin (R) (Pramlintide acetate) 1000mcg/ml, will be administered as a continuous infusion at a rate of 15mcg/hour, equivalent to the daily recommended maximum dosage of 360mcg/day.
Semaglutide Pen InjectorDrug
Also called Wegovy
Semaglutide from 0,25mg/week to 2,4mg/week
Sodium Chloride 0.9% InjDrug
Also called isotonic saline solution
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide and placebo | Active comparator | All subjects will receive weekly semaglutide inj. for 26 weeks. After 24 weeks of treatment, this group will be randomized to receive placebo, in addition to semaglutide for the last two weeks of the study. Receives: Drug: Semaglutide Pen Injector; Drug: Sodium Chloride 0.9% Inj |
| Semaglutide and pramlintide | Experimental | All subjects will receive weekly semaglutide inj. for 26 weeks. After 24 weeks of treatment, this group will be randomized to receive pramlintide, in addition to semaglutide for the last two weeks of the study. Receives: Drug: Pramlintide Acetate 1 MG/ML; Drug: Semaglutide Pen Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in kilocalorie (kCal) consumption at ad libitum meal test, from baseline, to after 26 weeks of semaglutide of which the last two weeks is with the addition of either pramlintide or placebo
Measured: From baseline at the start of the study(week 0), to the end of the study after 26 weeks
Secondary outcomes (5)
Difference in total weight loss between the subgroups (Obesity phenotypes)
Measured: From baseline (week 0) to end of study (week 26)
Change in appetite and satiety sensations as measured by Visual Analog Scale (VAS) prior to and following the meal tests
The meal test will be performed at baseline, after 24 weeks and at the end of the study(week 26). Prior to and following the meal tests a VAS measuring appetite and satiety sensation will be answered.
Measured: From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)
Change in gastric emptying rate assessed by paracetamol (acetaminophen) test
The gastric emptying test will be performed at baseline (week 0) and at the end of the study (week26).
Measured: From baseline (week 0) to end of study(week 26)
Total weight loss
Total weight loss from baseline, after 24 weeks, and at the end of the study( week 26) The results will be repoted as percentage (%) weight loss.
Measured: From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)
Total weight loss
Total weight loss from baseline, after 24 weeks, and at the end of the study( week 26) The results will be repoted as total weight loss in Kg
Measured: From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Apr 2025
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: suspended by the danish medical agency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All subjects will receive weekly semaglutide inj. for 26 weeks. After 24 weeks of treatment, the subjects will be randomized to receive either pramlintide or placebo, in addition to semaglutide for the last two weeks of the study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus Bogh Juhl, MD, phd, professor, Principal investigator, Head of endocrinology dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619015
- Sponsor's protocol ID
- 24/39715
- Other IDs
- 2024-510802-10-00
- Acronym
- TOTT
- Status last verified
- Apr 2026
- First submitted
- 28 Aug 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pramlintide on Top of Semaglutide in Obese People With Prediabetes
- ClinicalTrials.gov ID
- NCT06619015
- Acronym / sponsor ID
- TOTT / 24/39715
- Conditions
- Obesity, Appetite Regulation, PreDiabetes
- Keywords
- semaglutide, pramlintide, symlin, placebo, obesity, individualized medicine, tailoring treatment, Anti-Obesity Drugs
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: suspended by the danish medical agency
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 1 Oct 2024 (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 main aims of this clinical study is;
- To investigate if the results from a series of physiological tests and questionnaires prior to treatment, can be used to predict the treatment response to obesity medication
- To investigate the effect of combining semaglutide and pramlintide on various aspects of appetite, food preference and eating habits.
The study is planed as a 26 week, double blinded, randomized, placebo controlled trial. The goal is to include N=40. They will all receive weekly semaglutide injections. After 24 weeks they will be randomized to receive either an amylin analog (pramlintide) or placebo as a continuous infusion for two weeks, in addition to weekly semaglutide.
The results from this study will contribute to identifying possible predictors of treatment response, enabling optimal individualized medical weight loss treatment. As well as providing knowledge on the complex interplay between incretin hormones and their effects on appetite and eating habits.
Detailed description
Obesity is a major global health challenge and the prevalence of obesity is increasing. Presence of obesity increases the risk of several diseases, physical limitations and an increased mortality. When weightloss is wanted in order to avoid or treat some of these diseases, medical weight loss treatment is one of the options. Among these modified gut hormones, such as Glucagon Like Peptide -1 Receptor agonists (GLP-1RA). However, the individual response to GLP-1RA treatments varies considerably. Currently the best predictor of total weight loss is achieved weight loss after three months of treatment. With more pharmaceutical options to come, a trial and error approach is not appropriate. There is a need to identify possible pre-treatment predictors to treatment response.
This is one of the project\'s main aims. By being able to predict the treatment response, one can tailor the obesity treatment to the individual improving the treatment outcome.
Amylin is co-secreted with insulin from the pancreas in response to meals. It is found to have many similar effects in the body as GLP-1. However their combination, especially on appetite, food preferences and eating pattern is sparsely investigated. This is the other main aim of the project.
This clinical study will be a 26 week, randomized, double-blinded, placebo-controlled trial. Forty overweight (BMI ≥30kg/m2) individuals with pre-diabetes (HbA1c 39-47 mmol/mol) will all receive once-weekly semaglutide for 26 weeks. Semaglutide will be given in escalating doses aiming to reach the maximal dose of 2.4 mg (maximum dosage approved for treatment of overweight), but accepting lower maximal tolerable dosage.
After 24 weeks of treatment, they will be stratified according to their weight loss (\&lt;15% or ≧15%) and based on this stratification, block randomized 1:1 to receive either pramlintide or placebo(normal isotonic 0.9% saline solution) in addition to weekly semaglutide. Pramlintide will be continuously infused, starting at a dosage of 7,5 mcg/hour for three days, and if tolerated, the dosage will be increased to 15 mcg/hour for the remaining eleven days. Previous studies have found measurable changes in appetite after a single dosage of pramlintide, and measurable weight loss after two weeks of treatment. For the continuous infusion a commercially available insulin pump will be used.
At study start and, prior to semaglutide treatment, body composition, REE and gastric emptying rate will be measured. Various aspects of appetite will be assessed by the results from the meal tests, the "taste test", appetite assessment and eating related questionnaires. An appetite Visual Analog Scale (VAS) will be measured prior to, and following the standardized meal test and the ad libitum meal test. Satiety will be assessed by a VAS following the standardized meal test. Appetite related sensory specific desire will be assessed by the participants rating of a "taste test" consisting of a variety of small food samples representing the sensory profiles of sweet, sour, salt, bitter, fat, umami/savory and spicy, respectively. The "taste test" will be performed prior to the ad libitum test and as previously described. And satiation will be assessed by measuring calories consumed to reach fullness and terminate the meal at the ad libitum meal test. While the Food pleasure scale, Yale Food Addiction Scale 2.0, Dutch Eating Behavior Questionnaire and The Eating Disorder Quality of Life Scale questionnaires will assess hedonic, emotional and binge- eating patterns and eating related quality of life. The combined results of these physical measurements, questionnaires, appetite and hunger assessments will be used to identify the participants\&#39; main obesity driver or obesity "phenotype" similarly as previously described.
These tests will be repeated at the end of the study and the results compared. The "taste test" and ad libitum meal test will also be performed after 24 weeks, prior to the addition of either pramlintide or placebo.
Additionally blood samples will be taken at baseline, after 24 weeks and at the end of the study, measuring biomarkers related to metabolism, bone metabolism and organ specific biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- All subjects will receive weekly semaglutide inj. for 26 weeks. After 24 weeks of treatment, the subjects will be randomized to receive either pramlintide or placebo, in addition to semaglutide for the last two weeks of the study.
| Arm | Type | Receives |
|---|---|---|
| Semaglutide and placebo | Active comparator | Drug: Semaglutide Pen Injector, Drug: Sodium Chloride 0.9% InjAll subjects will receive weekly semaglutide inj. for 26 weeks. After 24 weeks of treatment, this group will be randomized to receive placebo, in addition to semaglutide for the last two weeks of the study. |
| Semaglutide and pramlintide | Experimental | Drug: Pramlintide Acetate 1 MG/ML, Drug: Semaglutide Pen InjectorAll subjects will receive weekly semaglutide inj. for 26 weeks. After 24 weeks of treatment, this group will be randomized to receive pramlintide, in addition to semaglutide for the last two weeks of the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI ≧ 30kg/m2
- HbA1c 39-47 mmol/mol (pre-diabetes)
- Male or female
- Aged >18 years of age and <70 years
- Negative pregnancy test, and willing to use contraceptives during the study period
Key exclusion criteria (11 listed)
- Presence of diabetes with or without treatment
- Current or recent (<6 months) treatment with GLP1 RA's
- Previous gastrointestinal surgery that might affect gastric emptying, nutritional absorption and postprandial GI peptide production
- History of acute or chronic pancreatitis
- Chronic kidney disease
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 |
|---|---|---|
| Pramlintide Acetate 1 MG/MLAlso: SymlinSymlin (R) (Pramlintide acetate) 1000mcg/ml, will be administered as a continuous infusion at a rate of 15mcg/hour, equivalent to the daily recommended maximum dosage of 360mcg/day. | Drug | Semaglutide and pramlintide |
| Semaglutide Pen InjectorAlso: WegovySemaglutide from 0,25mg/week to 2,4mg/week | Drug | Semaglutide and placebo, Semaglutide and pramlintide |
| Sodium Chloride 0.9% InjAlso: isotonic saline solutionPlacebo | Drug | Semaglutide and placebo |
Primary outcome
Change in kilocalorie (kCal) consumption at ad libitum meal test, from baseline, to after 26 weeks of semaglutide of which the last two weeks is with the addition of either pramlintide or placebo
Time frame: From baseline at the start of the study(week 0), to the end of the study after 26 weeks
5 secondary outcomes
Difference in total weight loss between the subgroups (Obesity phenotypes)
Time frame: From baseline (week 0) to end of study (week 26)
Change in appetite and satiety sensations as measured by Visual Analog Scale (VAS) prior to and following the meal tests
Time frame: From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)
Change in gastric emptying rate assessed by paracetamol (acetaminophen) test
Time frame: From baseline (week 0) to end of study(week 26)
Total weight loss
Time frame: From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)
Total weight loss
Time frame: From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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. This study is not recruiting at the moment.
Claus Bogh Juhl, MD, phd, professor principal investigator
Head of endocrinology dept.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pramlintide Acetate 1 MG/ML, Semaglutide Pen Injector and Sodium Chloride 0.9% Inj in people with Obesity and Appetite Regulation, run by Esbjerg Hospital - University Hospital of Southern Denmark 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 11 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: withdrawn, as of the sponsor's last update on 17 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in kilocalorie (kCal) consumption at ad libitum meal test, from baseline, to after 26 weeks of semaglutide of which the last two weeks is with the addition of either pramlintide or placebo (time frame: From baseline at the start of the study(week 0), to the end of the study after 26 weeks). 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 17 Apr 2026.