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Bremelanotide + Tirzepatide for Obesity (BMT-801 Trial)
Phase 2
Recruiting
Research Sponsored by Palatin Technologies, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female aged between 18-65 years of age, inclusive at the time of consent
Female subjects must have a negative urine pregnancy test at screening if of childbearing potential or be of non-childbearing potential
Must not have
Has multiple endocrine neoplasia syndrome type 2
Has personal or family history of MEN 2 syndromes or Medullary Thyroid Cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to week 8
Summary
This trial will test if combining bremelanotide with tirzepatide is safe and effective in treating obesity in people with a BMI between 30.0 and 45.0 kg/m
Who is the study for?
This trial is for adults with obesity, defined by a BMI of 30.0 to 45.0 kg/m2. Participants must be suitable for treatment with both Bremelanotide and Tirzepatide based on the study's specific requirements.
What is being tested?
The study tests if using Bremelanotide (BMT) together with Tirzepatide helps in treating obesity better than placebo. It's a controlled test where patients are randomly chosen to receive either the real drugs or a dummy drug without knowing which one they're getting.
What are the potential side effects?
Possible side effects may include nausea, headache, dizziness, fatigue, high blood pressure from Bremelanotide; and gastrointestinal issues like stomach pain or diarrhea from Tirzepatide.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I am not pregnant or cannot become pregnant.
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I will not have unprotected sex or will use double barrier protection if I do.
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I agree not to donate sperm during the trial.
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I am willing to self-inject medication.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with multiple endocrine neoplasia syndrome type 2.
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I or my family have a history of MEN 2 syndromes or Medullary Thyroid Cancer.
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I have been diagnosed with type 2 diabetes.
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I have a history of slow heartbeats or my heart rate is below 50 bpm.
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I have used bremelanotide (Vyleesi) in the last 6 months.
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I have high blood pressure or heart disease.
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I am taking oral medication that requires specific levels to work effectively.
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I am not pregnant, breastfeeding, nor planning to become pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in body weight between treatment arms
Secondary study objectives
Change in International Index of Erectile Function (IIEF)domain score
Change in Neck and Waist measurements with a Measuring Tape (Inches)
Change in Overall Appetite Suppression Score (OASS) as measured by Visual Analog Scale (VAS)
+21 moreOther study objectives
The number of participants with Clinically significant changes in clinical laboratory test
The number of participants with Treatment-emergent adverse events (TEAEs).
The number of participants with clinically significant changes in vital signs
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: PlaceboActive Control1 Intervention
Group II: Tirzepatide and Bremelanotide Combination TherapyActive Control2 Interventions
Group III: Tirzepatide MonotherapyPlacebo Group1 Intervention
N=1
Group IV: Bremelanotide MonotherapyPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Palatin Technologies, IncLead Sponsor
11 Previous Clinical Trials
2,904 Total Patients Enrolled
Robert JordanStudy DirectorPalatin
5 Previous Clinical Trials
1,502 Total Patients Enrolled