Effect of GLP-1 Analogue ROSE-010 on Appetite in Overweight and Obese Subjects
NCT06621017 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-09-05
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.
Conditions
- Obesity; Overweight
Interventions
- DRUG
-
ROSE-010 99 mcg
Sub-cutaneous injection of ROSE-010 solution
- DRUG
-
Sub-cutaneous injection of saline solution
- DRUG
-
ROSE-010 150 mcg
Sub-cutaneous injection of ROSE-010 solution
Sponsors & Collaborators
-
Rose Pharma Inc
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-26
- Primary Completion
- 2025-02-27
- Completion
- 2025-02-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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