Clinical Trial Search

Primary: Change From Baseline in Hyperphagia in Prader-Willi Syndrome (PWS) Questionnaires- Responsiveness (HPWSQ-R) Total Score at End-of-treatment (Day 15) — -15.6; -8.9 score…

Primary: Microbiome Analysis: Alpha Diversity — 4.89 Shannon index

Primary: Intelligence Quotient — 85.9; 104.3; 103.2 units on a scale

Primary: Peak Growth Hormone (GH) on the GH Stimulation Test — 40.1; 25.2 ng/ml — p=<0.05

Primary: Change in Weight — -.5 kg — p=.07

Primary: Change in Efficacy of Peptide Intranasal Oxytocin (IN-OXT) — -6.08; -6.64 score on a scale

Primary: Change in Body Weight From Baseline to 12 Months — 1.09; 1.55 lbs

Primary: Change in Preference- Liking — 6.5; 4.5 units on a scale

Primary: Total Food Intake (Lunch Buffet) at 24 Months — 2540.1; 721 kJ

Primary: Safety — 4 participants

Primary: Change in zBMI — -0.048; 0.013; 0.011 z-score — p=0.051

Primary: Treatment Emergent Adverse Events — 1; 0; 1; 0 Events

Primary: Number of Participants Who Reported Nausea at 10 Minutes Post Treatment — 17; 18 Participants

Primary: The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract — 1310; 1073; 1118; 1188 pg*min/mL

Primary: 24 Hour Average Plasma Growth Hormone Concentration — 0.4; 1.2; 4.1 ng/mL

Primary: Food Intake — 849; 975 kcal — p=0.26

Primary: Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3 — 10.95; -523.15 kilocalories (kcal) — p=<.0001

Primary: Change in Craving Score — -0.7; -0.3 score — p=< 0.001

Primary: Change in Brain Response From Baseline to 2-weeks Post High UPF or 2 Weeks no UPF Diet — 0.02; 0.13 arbitrary units

Primary: Infant Weight-for-Length Z Scores — 0.43; 0.12 z-score — p=0.07

Primary: Dietary Recalls (Calorific Intake) — 1900.9; 2054.3 kcal

Primary: Gastric Emptying of Solids Half-Time (T 1/2) — 109; 88 minutes — p=0.057

Primary: Percent Change of Body Mass Index (BMI) as Calculated by the Formula: Body Weight in kg Divided by Height in Meters². — 1.7; 3.5 percent change from baseline — p=0.40

Primary: Amplitude of Eyeblink Startle Responses — 0.006; 0.001; 0.008; 0.001 microvolts

Primary: Nucleus Accumbens Blood Flow — 1.13; 1.16; 1.15; 1.21 ml/g/min per ml/g/min

Primary: ACTIVATION/NON ACTIVATION OF SPECIFIC BRAIN AREAS, EVALUATED BY FUNCTIONAL MAGNETIC RESONANCE — 585.57; 667.92; 511.22 BOLD

Primary: Kilocalories Consumed — 412; 553 Kilocalorie

Primary: Ad Libitum Food and Beverage Intake (g) — 71.5; 81.9; 24.9; 33.6 g — p=0.45

Primary: Child Body Mass Index — 17.83; 18.78 kg/m-squred

Primary: Change in Food Image Ratings — -5.1; -.3; -6.8; -2.7 Score change from baseline — p=0.038