ROSE-010 for Obesity

Recruiting in Cincinnati (>99 mi)

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+