At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Daily Administrations of the GLP-1 Analogue ROSE-010 on Appetite and Food Intake in Overweight and Obese Subjects
In Brief
A Phase 2 clinical trial evaluating ROSE-010 99 mcg, Placebo, and 1 other intervention for Obesity; Overweight. Completed, enrolled 40 participants across 1 site.
Signals
Detailed Summary
The primary objective of this study is to assess the efficacy of ROSE-010 on food intake in female subjects with overweight and obesity. The secondary objectives of this study are the following: * To assess the efficacy of ROSE-010 on hunger; * To assess the efficacy of ROSE-010 on satiety; * To assess the efficacy of ROSE-010 on prospective consumption; * To assess the efficacy of ROSE-010 on desire to eat; * To assess the efficacy of ROSE-010 on palatability; * To characterize the pharmacokinetics (PK) of ROSE-010 following subcutaneous (SC) administration on Day 1 and Day 7; and * To evaluate safety and tolerability of SC administrations of ROSE-010 to overweight and obese subjects.
Study Details
Timeline
Arms & Interventions
Saline solution
ROSE-010 solution, 99 mcg, 0.5 ml
ROSE-010 solution, 150 mcg, 0.5 ml
Interventions
Sub-cutaneous injection of ROSE-010 solution
Sub-cutaneous injection of saline solution
Sub-cutaneous injection of ROSE-010 solution