ROSE-010 for Obesity

Overseen By Study Principal Investigator, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Rose Pharma Inc

Must not be taking: Anticholinergics, Opiates, GLP-1 agonists, others

Disqualifiers: Diabetes, Thyroid disease, Depression, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ROSE-010 to determine if it can reduce food intake and improve feelings of fullness in women with overweight or obesity. Researchers aim to assess the effectiveness and safety of ROSE-010 at different doses. Participants will receive either ROSE-010 or a placebo (a harmless substance resembling the treatment) for comparison. Eligible women have a body mass index (BMI) between 27 and 35, classifying them as overweight or obese according to standard health guidelines, and are in generally good health. As a Phase 2 trial, this research measures ROSE-010's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescribed or over-the-counter medications, except approved contraceptives, at least 14 days before the trial starts and throughout the study. However, medications for treating side effects during the trial may be allowed by the study doctor.

Is there any evidence suggesting that ROSE-010 is likely to be safe for humans?

Research has shown that ROSE-010 is generally safe for people. In earlier studies, both high and low doses of ROSE-010 proved effective and were well-tolerated by participants. Those taking ROSE-010 consumed less during meals and lost weight without experiencing major stomach problems.

Another study found that lab tests for ROSE-010 did not reveal any serious health issues, indicating no major health concerns. Additionally, there were no significant delays in digestion, which is a positive sign for its safety.

Overall, early research suggests that ROSE-010 is safe for use, with only a few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for obesity, which often involve lifestyle changes, medications like orlistat, or even surgical options, ROSE-010 offers a novel approach. Researchers are excited about ROSE-010 because it uses a unique peptide-based mechanism that targets specific pathways in the body to potentially regulate appetite and weight. This approach could provide a more targeted and possibly more effective option for individuals struggling with obesity. Additionally, ROSE-010 is administered through an injection, which might offer different absorption and efficacy compared to oral medications. These features make ROSE-010 a promising candidate in the fight against obesity.

What evidence suggests that ROSE-010 might be an effective treatment for obesity?

Studies have shown that ROSE-010 can help people eat less and lose weight. In this trial, participants may receive either 150 mcg or 99 mcg of ROSE-010. Research indicates that patients who took 150 mcg of ROSE-010 ate up to 17% less than those who took a placebo, a harmless solution with no active ingredients. It also slowed their eating pace, aiding in appetite control. Earlier tests showed that ROSE-010 helped people consume fewer calories during meals and lose weight, while being gentle on the stomach. These findings suggest that ROSE-010 could effectively manage weight by reducing hunger and food intake. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for women who are overweight or obese. Participants will be testing the effects of a drug called ROSE-010 on their appetite and eating habits. They should not have any health conditions that could interfere with the study.

Inclusion Criteria

Body mass index greater or equal to 27 and less than nor equal to 35 kg/m2 at Screening

I am not pregnant, breastfeeding, or planning to become pregnant soon.

My overall health is good as confirmed by recent medical exams.

Exclusion Criteria

My obesity is caused by a hormonal disorder or a specific genetic condition.

I have been diagnosed with Major Depressive Disorder in the last 2 years.

Known allergy to any ingredient of ROSE-010 or any history of severe allergic reaction (including drugs, food, insect bites, or environmental allergens)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily subcutaneous administrations of ROSE-010 or placebo for 7 consecutive days

1 week

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ROSE-010

Trial Overview The trial is examining how well ROSE-010 can reduce food intake, hunger, and increase feelings of fullness in participants. It involves comparing two doses of ROSE-010 against a placebo to see which is more effective.

How Is the Trial Designed?

Group I: ROSE-010 99 mcg Experimental Treatment 1 Intervention

ROSE-010 solution, 99 mcg, 0.5 ml

Group II: ROSE-010 150 mcg Experimental Treatment 1 Intervention

ROSE-010 solution, 150 mcg, 0.5 ml

Group III: Placebo Placebo Group 1 Intervention

Saline solution

Who Is Running the Clinical Trial?

Rose Pharma Inc

Lead Sponsor

Trials

1

Recruited

40+

Citations

1. rosepharmainc.com rosepharmainc.com/science-obesity-appetite-control/

Science - Obesity & Appetite Control 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 ...

2. linkedin.com linkedin.com/posts/rose-pharma-inc_obesityweek-rose010-activity-7387542788604710912-cNKZ

Rose Pharma to present ROSE-010 Phase 2a results at ... In Phase 2a clinical testing, ROSE-010 has demonstrated reductions in mealtime caloric intake and weight loss with a favorable GI tolerability ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36121652/

Weight Loss Outcomes Associated With Semaglutide ... Of the 102 patients who were followed up at 6 months, 89 (87.3%) achieved weight loss of 5% or more, 56 (54.9%) achieved weight loss of 10% or ...

4. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2025.1548346/full

Improvement of irritable bowel syndrome with glucagon ... Results: The study found that ROSE-010 (100 µg) significantly lowered pain intensity in IBS patients compared to a placebo, with an overall odds ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/00365521.2022.2041084

Full article: Pain relief and pain intensity response to GLP-1 ... In summary, all data and results clarified that both high and low dose of ROSE-010 were effective and tolerable for controlling IBS symptoms, ...

6. journals.physiology.org journals.physiology.org/doi/abs/10.1152/ajpgi.00076.2012

Effect of a glucagon-like peptide 1 analog, ROSE-010, on ... Laboratory safety results were not clinically significant. In IBS-C, ROSE-010 delayed gastric emptying of solids but did not retard colonic transit or alter ...

7. ctv.veeva.com ctv.veeva.com/study/effect-of-glp-1-analogue-rose-010-on-appetite-in-overweight-and-obese-subjects

Effect of GLP-1 Analogue ROSE-010 on Appetite in ... The primary objective of this study is to assess the efficacy of ROSE-010 on food intake in female subjects with overweight and obesity.