Pramlintide acetate for Obesity | Prediabetes

Inclusion criteria

• {"criterion_text":"- BMI ≧ 30kg/m2\n- Pre-diabetes (HbA1c 39-47 mmol/mol)\n- Male or female\n- Aged >18 years of age\n- Negative pregnancy test, and willing to use contraceptives during the study period"}

Exclusion criteria

• {"criterion_text":"- Presence of diabetes with or without treatment.\n- Recent (<3 months) weight loss ≧ 1% of body weight.\n- Presence of Binge eating disorder.\n- Current or recent (<6 months) treatment with GLP1 RA’s.\n- Previous gastrointestinal surgery that might affect gastric emptying, nutritional absorption and postprandial GI peptide production.\n- History of acute or chronic pancreatitis.\n- Chronic kidney disease.\n- Use of any antipsychotic drugs.\n- Use of any antiresorptive or bone-anabolic drugs or fractures within < 6 months.\n- Use of systemic oral glucocorticoids within < 6 months.\n- Newly (< 3 months) initiated hormonal contraceptive or other hormone therapy."}

Primary endpoints

• {"endpoint_text":"- Change in kilocalorie (kCal) consumption at ad libitum meal test, from baseline, to after 25 weeks, and after 26 weeks of semaglutide treatment, of which the last week is with the addition of pramlintide.","definition_or_measurement_approach":"Measured as change in kilocalorie (kCal) consumption during an ad libitum meal test at baseline, after 25 weeks of treatment, and after 26 weeks (the last week includes addition of pramlintide)."}

Secondary endpoints

• {"endpoint_text":"- Total weight loss from baseline, after 25 weeks, and at the end of the study, both as kg and as % of total body weight","definition_or_measurement_approach":"Measured change in body weight from baseline at 25 weeks and at end of study, reported in kilograms and percent of baseline body weight."}
• {"endpoint_text":"- Difference in total weight loss between the phenotypes","definition_or_measurement_approach":"Comparison of total weight loss between predefined obesity phenotypes (phenotyping details in protocol)."}
• {"endpoint_text":"- Change in appetite and satiety sensations as measured by VAS prior to and following the meal tests performed at baseline, after 25 weeks, and at the end of the study","definition_or_measurement_approach":"Appetite and satiety assessed using Visual Analogue Scales (VAS) before and after meal tests at baseline, 25 weeks, and end of study."}
• {"endpoint_text":"- Change in gastric emptying rate assessed by paracetamol test performed at baseline, after 25 weeks, and at the end of the study","definition_or_measurement_approach":"Gastric emptying rate measured using the paracetamol absorption test at baseline, 25 weeks, and end of study."}

Denmark

Earliest CTIS Part Ii Submission Date

14-11-2024

Latest Decision Or Authorization Date

03-12-2024

Processing Time Days

19

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Esbjerg Sygehus

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties code: 1 (as listed in CTIS thirdParties)","organisation_type":"Hospital/Clinic/Other health care facility"}