NCT06621017

Effect of GLP-1 Analogue ROSE-010 on Appetite in Overweight and Obese Subjects

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Rose Pharma Inc · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, placebo-controlled, double-blind, parallel-group Phase 2 study evaluating the efficacy, safety, and PK of daily administrations of the GLP-1 analogue ROSE-010 on appetite and food intake in overweight and obese female subjects. The study is planned to include 3 parallel groups, as follows: Group 1: 99 mcg ROSE-010 (15 subjects) administered SC once daily for 7 consecutive days. Group 2: 150 mcg ROSE-010 (15 subjects) administered SC once daily for 7 consecutive days. Group 3: Placebo (10 subjects) administered SC once daily for 7 consecutive days. On Day 1, subjects will be randomized to receive ROSE-010 or placebo. Study drug will be administered SC once daily (30 minutes before lunch) for 7 consecutive days (Days 1 to 7). Assessments of hunger, satiety, prospective consumption, desire to eat, palatability, and nausea will be performed. Blood samples will be collected to evaluate PK.

Conditions

• Obesity; Overweight

Interventions

Type	Name	Description
DRUG	ROSE-010 99 mcg	Sub-cutaneous injection of ROSE-010 solution
DRUG	Placebo	Sub-cutaneous injection of saline solution
DRUG	ROSE-010 150 mcg	Sub-cutaneous injection of ROSE-010 solution

Timeline

• Start date: 2024-09-26
• Primary completion: 2025-02-27
• Completion: 2025-02-27
• First posted: 2024-10-01
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study