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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

Awards & highlights

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 8 for reporting.

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 more

Other 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: Tirzepatide and Bremelanotide Combination TherapyActive Control2 Interventions

Group II: PlaceboActive Control1 Intervention

Group III: Tirzepatide MonotherapyPlacebo Group1 Intervention

N=1

Group IV: Bremelanotide MonotherapyPlacebo Group1 Intervention

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Palatin Technologies, IncLead Sponsor

11 Previous Clinical Trials

2,598 Total Patients Enrolled

Robert JordanStudy DirectorPalatin

5 Previous Clinical Trials

1,531 Total Patients Enrolled

~40 spots leftby Dec 2024

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