Tailoring Obesity Treatment Trial

NCT06619015 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: 24/397152024-510802-10-00
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The two main aims of this clinical study is;

1. 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. 2.To investigate the effect of combining semaglutide and pramlintide on various aspects of appetite, food preference and eating habits.

Conditions

Obesity; Appetite Regulation; PreDiabetes

Keywords

semaglutide; pramlintide; symlin; placebo; obesity; individualized medicine; tailoring treatment; Anti-Obesity Drugs; Appetite Regulation; Treatment Effect Heterogeneity; PreDiabetes

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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

  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

  From baseline (week 0) to end of study(week 26)

• Total weight loss

  From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)

• Total weight loss

  From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)

Other Outcomes (2)

• Change in sensory specific desires as measured by a taste test

  From baseline (week 0) to after 24 weeks, and to the end of the study (week 26)

• Change in hedonic eating behavior as measured by questionnaires

  From baseline (week 0) to after 24 weeks, and to the end of the study (week 26)

Study Arms (2)

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.

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.

Drug: Pramlintide Acetate 1 MG/ML; Drug: Semaglutide Pen Injector

Interventions

Pramlintide Acetate 1 MG/ML DRUG

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.

Also known as: Symlin

Semaglutide and pramlintide

Semaglutide Pen Injector DRUG

Semaglutide from 0,25mg/week to 2,4mg/week

Also known as: Wegovy

Semaglutide and placebo; Semaglutide and pramlintide

Sodium Chloride 0.9% Inj DRUG

Placebo

Also known as: isotonic saline solution

Semaglutide and placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (1)

University hospital of Southern Denmark

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Obesity; Prediabetic State

Interventions

pramlintide; semaglutide; Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Claus Bogh Juhl, MD, phd, professor

  Head of endocrinology dept.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: October 1, 2024
• Study Start: April 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

DK (1)