ROSE-010 for Obesity

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Rose Pharma Inc

Prior Safety Data

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.

Research Team

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.

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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)

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Treatment Details

Interventions

ROSE-010 (GLP-1 Analogue)

Trial OverviewThe 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

3Treatment groups

Experimental Treatment

Placebo Group

Group I: ROSE-010 99 mcgExperimental Treatment1 Intervention

ROSE-010 solution, 99 mcg, 0.5 ml

Group II: ROSE-010 150 mcgExperimental Treatment1 Intervention

ROSE-010 solution, 150 mcg, 0.5 ml

Group III: PlaceboPlacebo Group1 Intervention

Saline solution