Weight Loss
| Group | Value (kg) |
|---|---|
| Oxytocin | 88.3 |
| Placebo | 91.9 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This research study will test if oxytocin, delivered by nasal spray, will promote weight loss in children, adolescents, and adults with Hypothalamic Obesity as compared to a placebo. The study is divided into two parts. During the first part, subjects will receive either oxytocin or placebo. In the second part, subjects will "cross-over" to receive the other treatment - either oxytocin or placebo. During study visits participants will do blood tests, physical exams, metabolic testing, a MRI scan, and some surveys and questionnaires.
Experimental
Syntocinon (= Oxytocin), then Placebo
Week 0 to Week 7: Intranasal oxytocin, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks) Week 8 to Week 11: Washout Week 12 to Week 20: Intranasal placebo, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks) \*Dose Escalation, as appropriate, at 2 Weeks
Experimental
Placebo, then Syntocinon (= Oxytocin)
Week 0 to Week 7: Intranasal placebo, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks) Week 8 to Week 11: Washout Week 12 to Week 20: Intranasal oxytocin, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)
Outcomes the sponsor listed as primary.
Weight Loss
Time frame · Assessed at the beginning and end of each Intervention Period (Intervention 1: Visit 1 to Visit 4 = 8 Weeks, Intervention 2: Visit 5 to Visit 8 = 8 Weeks)
The primary objective of this study is to determine whether treatment with 8 weeks of intranasal OXT (relative to 8 weeks of placebo) will promote weight loss in children and adolescents with brain tumors and hypothalamic obesity syndrome ages 10 to 35 years. Specifically, the primary outcome will be: the difference of the post-treatment weight between the two periods (treatment vs. placebo); the statistical model will include the difference of the baseline weight between the two periods and the sequence (OXT-PBO versus PBO-OXT).
Peripheral Oxytocin Area Under the Curve (AUC)
Time frame · Assessed during each treatment block: at either initial lower dose at baseline (week 0 & week 12) or increased dose at 2 weeks (week 2 & week 15); 50% of participants at each set.
We will determine the immediate peripheral pharmacokinetics of intranasal oxytocin (versus placebo/endogenous oxytocin). In order to minimize participant burden, each participant had the assessment at one time point with either the low or high dose of oxytocin. And at one point during the placebo block. For this exploratory outcome, visits representing lower dose and higher dose oxytocin were Combined versus lower and higher dose placebo.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (kg) |
|---|---|
| Oxytocin | 88.3 |
| Placebo | 91.9 |
| Group | Value (Concentration (min*pg/mL)) |
|---|---|
| Oxytocin | 101792 |
| Placebo | 99110 |
| Group | Value (msec) |
|---|---|
| Oxytocin | 282 |
| Placebo | 247 |
| Group | Value (% of total kcal offered) |
|---|---|
| Oxytocin | 72.4 |
| Placebo | 72.6 |
| Group | Value (% of total kcal offered) |
|---|---|
| Oxytocin | 72.6 |
| Placebo | 67.7 |
| Group | Value (kcal/kg lean mass/day) |
|---|---|
| Oxytocin | 129.5 |
| Placebo | 127.2 |
| Group | Value (Ratio (L C02/L 02)) |
|---|---|
| Oxytocin | 0.8 |
| Placebo | 0.8 |
| Group | Value (percent body fat) |
|---|---|
| Oxytocin | 50.1 |
| Placebo | 50.6 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Syntocinon (Intranasal Oxytocin)1\) Intranasal oxytocin, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks) Syntocinon: The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin. | 0 / 12 | 0 / 12 | 12 / 12 |
| Placebo1\) Intranasal placebo, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks) Placebo (for Syntocinon): The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin. | 0 / 12 | 0 / 12 | 12 / 12 |
| OverallAll Participants from Both Treatment Groups. | 0 / 12 | 0 / 12 | 12 / 12 |
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