Science
Obesity & Appetite Control
A Novel Approach to Meal-Time Appetite Suppression. ROSE-010 offers a fast-acting, short-duration alternative to long-acting GLP-1 drugs for appetite control and weight management.
Phase 1 Clinical Trial in Obesity
A randomized, placebo-controlled trial was conducted to assess ROSE-010’s impact on appetite suppression and food intake:
Study Design:
- N=12 men and women, ages 35-65, BMI 27-32 kg/m².
- Double-blind, crossover design testing placebo, 100 µg, and 150 µg doses.
- Subcutaneous injection administered 30 minutes before a standardized meal.
- Primary Endpoint: Amount of food consumed (grams) during a meal.
- Secondary Endpoints: Hunger, satiety, desire to eat, and nausea levels were monitored using visual analog scales (VAS).
Key Results:
- Food Intake Reduction: Patients ate up to 17% less with 150 µg ROSE-010 compared to placebo.
- Eating Rate: Patients ate 13% slower with 150 µg and 6% slower with 100 µg ROSE-010.
- Satiety & Hunger Suppression: ROSE-010 reduced hunger and food consumption, with no rebound hunger effect at 4 hours post-meal.
- Gastric Emptying Delay: Gastric emptying was delayed by ~2 hours, a known mechanism of GLP-1-mediated appetite suppression.
- Tolerability: Mild nausea was observed, resolving within 3 hours, with no serious side effects.
Phase 2 Clinical Trial in Overweight & Obesity
A randomized, placebo-controlled trial to assess ROSE-010’s impact on food consumption, appetite and weight loss
- N=40 women, ages 18-65, BMI 27-35 kg/m².
- Double-blind, 3 treatment groups placebo (N=10), 99 µg (N=15), and 150 µg (N=15) doses.
- Subcutaneous injection administered 30 minutes before a standardized meal, once daily for 7 days.
- Primary Endpoint: Efficacy of ROSE-010 on food consumption.
- Secondary Endpoints: Hunger, satiety, desire to eat, prospective consumption and nausea levels were monitored using visual analog scales (VAS).
- Effect of 7 days treatment with ROSE-010 on body weight.
Key Results:
- Food consumption overall (both kcals and weight) was statistically significantly lower for the ROSE-010 groups compared to the placebo group across 7 days.
- Mean food consumption was 30% less in the ROSE-010 groups compared to placebo.
- The 150 mcg ROSE-010 group consistently had the lowest values for appetite scores, reflecting a dose response.
- Nausea was low overall in the ROSE-010 groups and transient with recovery after 2.5 hours..
- The 99 mcg ROSE-010, 150 mcg ROSE-010, and placebo groups experienced a 2.68% (2.01 kg), 3.03% (2.50 kg), and 1.07% (0.92 kg) decrease in body weight, respectively, on Day 8 compared to baseline.
Implications for Weight Management
- Addresses GLP-1 Discontinuation Issues: Many patients discontinue long-acting GLP-1s due to persistent nausea and other side effects. ROSE-010’s short duration may improve tolerability and adherence.
- As-Needed Weight Management: ROSE-010 may be used for meal-specific appetite suppression, providing a flexible alternative for patients who cannot tolerate long-acting GLP-1 therapies.
