Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03649477) enrolled 130 people across three groups: 44 received the higher dose of LV-101 (9.6 mg), 43 received the lower dose (3.2 mg), and 43 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in extreme hunger (called hyperphagia), obsessive and compulsive behaviours, anxiety, and overall clinical impression in participants, most likely those with Prader-Willi syndrome. Two participants in the higher-dose group did not complete the study; everyone else finished. The reported data shows the following score changes from the start of the trial to the end. For extreme hunger (scored 0–36, where lower is better), scores dropped by 3.4 points in the higher-dose group, 5.4 points in the lower-dose group, and 2.2 points in the placebo group. For obsessive and compulsive behaviours (scored 0–40), scores dropped by 3.0 points, 3.1 points, and 2.4 points respectively. For anxiety (scored 0–56), the reported reductions were 4.3 points, 8.3 points, and 4.5 points. For overall clinical impression (scored 1–7), the reported scores at the end were 3.6, 3.4, and 3.9 across the three groups. A subset analysis of the hunger questionnaire also showed score reductions of 3.3, 4.6, and 2.2 points for the three groups. The reported data shows changes across all three groups, including the placebo group. What these numbers mean in terms of real-world benefit or harm is not something that can be determined from the figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 36633570) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Obesity Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with Prader-Willi syndrome (PWS) confirmed by genetic testing
- A parent or legal guardian is willing and able to sign a consent form on the participant's behalf, and the participant themselves can sign an assent form if appropriate
- You are in PWS Nutritional Phase 3, meaning you feel hungry almost all the time and rarely feel full
Who may not be able to join:
- You currently live in a group home
- You have been diagnosed with Schaaf-Yang syndrome or another genetic, hormonal, or chromosomal condition that affects thinking or learning
- You have started a new diet plan or changes to your eating environment within the last month before screening
- Your regular medications or supplements have changed in dose within the last 3 months, or are expected to change during the study (small adjustments to growth hormone of 10% or less are acceptable)
- You have a heart or cardiovascular condition, epilepsy (seizures), frequent migraines, or severe asthma
- You have had more than 3 sinus infections in the past 12 months, or have a nasal condition that could affect how a nasal spray is absorbed
- You are not willing to avoid nasal saline rinses, nasal irrigation, or other nasal sprays for 2 weeks before the study begins and throughout the first 8 weeks of the study
- You have used weight loss medication, or certain hormones called oxytocin, carbetocin, or vasopressin in the last 6 months
- You have taken part in another clinical trial involving an experimental drug or device in the last 6 months, or are currently in one
- The study doctor believes, for any reason, that joining the study would not be appropriate or safe for you (confirm with trial site)
⚠️ Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Hyperphagia Behavior; Obsessive and Compulsive Behaviors
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.