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GLP-1 Analogue

ROSE-010 for Obesity

Phase 2
Waitlist Available
Research Sponsored by Rose Pharma Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subjects of non-childbearing potential must be either surgically sterile (ie, had a hysterectomy, bilateral tubal ligation, bilateral salpingectomy, and/or bilateral oophorectomy at least 26 weeks prior to Screening) or postmenopausal (ie, have experienced spontaneous amenorrhea for at least 2 years, with a follicle-stimulating hormone level in the postmenopausal range at Screening based on the central laboratory's ranges)
Be older than 18 years old
Must not have
Obesity induced by other endocrinologic disorders (eg, Cushing syndrome, acromegaly, inadequately treated hypothyroidism) or diagnosed monogenic or syndromic forms of obesity (eg, melanocortin 4 receptor deficiency or Prader-Willi syndrome)
A history of Major Depressive Disorder within the last 2 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6.5 hours

Summary

This trial aims to study the effects of ROSE-010 on food intake in overweight and obese women. The study will also look at how ROSE-010 affects hunger, fullness, future eating

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from taking ROSE-010 may include reactions at the injection site, gastrointestinal issues like nausea or diarrhea, headaches, and potential changes in blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who cannot have children because I've had surgery or am postmenopausal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My obesity is caused by a hormonal disorder or a specific genetic condition.
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I have been diagnosed with Major Depressive Disorder in the last 2 years.
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I or my family have a history of medullary thyroid cancer or MEN2.
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My thyroid condition is not under control.
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I have high blood sugar or have been diagnosed with diabetes.
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I do not have major stomach or bowel problems that affect how food moves through my body.
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I have had gallbladder issues or my gallbladder removed in the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6.5 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6.5 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Food consumption
Secondary study objectives
Desire to eat
Hunger
Nausea
+7 more

Trial Design

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

Find a Location

Who is running the clinical trial?

Rose Pharma IncLead Sponsor
~0 spots leftby Dec 2024
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