Tirzepatide in PWS, HO and GNSO

ConditionsPrader-Willi Syndrome Hypothalamic Obesity Obesity/Therapy

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-26

SponsorGrace Kim

About this trial

This research study is comparing the effectiveness of a weight loss medication called Tirzepatide in young adults with Prader-Willi Syndrome and/or hypothalamic obesity, as compared to young adults with obesity that is unrelated to a genetic syndrome or underlying medical cause. These groups will be given medication for 1 year to see how weight and other health factors are effected by the medication.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) with either 1) genetically confirmed diagnosis of PWS, 2) hypothalamic obesity as defined by damage to the medial hypothalamic region resulting in dysregulation of satiety and energy balance as diagnosed by a physician, 3) general obesity unrelated to a genetic syndrome or underlying medical condition

In a stable care setting at least 6 months prior to enrollment

Able and willing to participate in study visits including tolerating blood draws, urine samples and tolerate DXA scan.

Ability to take weekly subcutaneous tirzepatide

Disqualifiers

Current or recent (within 3 months of start of study drug initiation) use of weight loss medications

Current use of insulin or sulfonylurea or other medication affecting insulin secretion or GLP1 clearance

Current or prior use of any GLP1A or DPP4 inhibitor during the 6 months before screening

Any medications that may affect the study endpoints

Trial design

Design model

Parallel

Treatments tested in this trial

Tirzepatide
Drug
Subjects will take Tirzepatide for 48 weeks

Treatment groups

36 Participants

are divided into 3 treatment groups

Group A: Prader-Willi SyndromeActive comparator 1 intervention

Group B: Hypothalamic ObesityActive comparator 1 intervention

Group C: General Non-Syndromic ObesityActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in weight

Weight will be measured in kilograms through anthropometric measurements. Change in percent weight from baseline to week 48 of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity will then be assessed.

Time frame

48 weeks

Secondary outcomes

Change in BMI

Change in BMI from baseline to 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity through anthropometric measurements. BMI will be calculated using weight (kg) and height (m) which will be combined to report BMI in kg/m\^2. The percent change in this BMI value from baseline to 48 weeks will be calculated.

Time frame

48 weeks

Change in fat mass

Change in fat mass (measured in kg by DXA scan) from baseline to 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity.

Time frame

48 weeks

Change in appetite - CoEQ (Control of Eating Questionnaire)

Change in appetite during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity using an appetite questionnaire (CoEQ - Control of Eating Questionnaire). CoEQ is a 21-item scale to assess the severity and type of food cravings an individual experiences using a visual analog scale. Higher scores indicate higher severity of hyperphagia.

Time frame

48 weeks

Change in appetite - Physician Rated Hyperphagia Severity Scale

Change in appetite during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity assed with a physician rated hyperphagia severity scale. This is a 5 point scale (0 to 5) to rate clinical imppression of hyperphagia severity. Higher scores mean more severity.

Time frame

48 weeks

Other outcomes

Change in safety markers -CBC

Change in safety markers during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity including: Complete Blood Count (CBC). This will be done with standard CBC assays via blood sample

Time frame

48 weeks

Change in safety markers - CMP

Change in safety markers during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity including: Comprehensive Metabolic Panel (CMP). This will be done with standard CMP assays via blood sample.

Time frame

48 weeks

Change in safety markers - coagulation factor assay PT [prothrombin time]

Change in safety markers during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity including: PT \[prothrombin time\], This assay will be done on drawn blood samples.

Time frame

48 weeks

Change in safety markers - coagulation factor assay- PTT [Activated Partial Thromboplastin Time ]

Change in safety markers during 48 weeks of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity including: , PTT \[Activated Partial Thromboplastin Time \].This assay will be done on drawn blood samples.

Time frame

48 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Grace Kim

Lead sponsor

Seattle Children's Hospital

Sponsor institution

Vanderbilt University Medical Center

Collaborator

Children's Hospitals and Clinics of Minnesota

Collaborator

Seattle Children's Hospital

Collaborator

Source ClinicalTrials.gov

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