108 Participants Needed

Bremelanotide + Tirzepatide for Obesity

(BMT-801 Trial)

Recruiting at 3 trial locations
NH
CH
SW
Overseen BySamantha Wagner
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Palatin Technologies, Inc
Must be taking: Tirzepatide
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you are taking certain medications like cyclosporine A, long-term corticosteroids, or anti-obesity medications within 90 days prior to screening. Also, if you are taking oral drugs that depend on specific concentrations for efficacy, you may not be eligible due to potential interactions with bremelanotide.

What data supports the idea that Bremelanotide + Tirzepatide for Obesity is an effective drug?

The available research shows that Tirzepatide, one of the components of the drug, is effective for weight loss in people with obesity. Studies have demonstrated that Tirzepatide helps with significant weight loss and is safe to use. It works by reducing appetite and improving feelings of fullness, which helps people eat less and lose weight. While the research focuses on Tirzepatide alone, it suggests that the drug could be effective for treating obesity.12345

What safety data exists for the combination of Bremelanotide and Tirzepatide for obesity treatment?

The provided research does not contain specific safety data for the combination of Bremelanotide and Tirzepatide for obesity treatment. The studies focus on bombesin receptor antagonists and agonists, which are unrelated to Bremelanotide and Tirzepatide. Therefore, no relevant safety data for this treatment combination is available in the provided research.678910

Is the drug Tirzepatide a promising treatment for obesity?

Yes, Tirzepatide is a promising drug for obesity. It can significantly reduce body weight by more than 20% and improve overall health by managing blood sugar levels and enhancing insulin sensitivity. This makes it an appealing option for treating obesity and related health issues.2341112

What is the purpose of this trial?

This is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of bremelanotide (BMT) used in combination with tirzepatide therapy in the treatment of obesity in subjects with a BMI ranging from 30.0 to 45.0 kg/m2 (inclusive).

Research Team

RJ

Robert Jordan

Principal Investigator

Palatin

Eligibility Criteria

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.

Inclusion Criteria

Female subjects must agree not to donate eggs for any purpose
Have a body mass index (BMI) of 30.0 to 45.0 kg/m^2 at screening
I can follow all study rules and visit schedules.
See 6 more

Exclusion Criteria

I have been diagnosed with multiple endocrine neoplasia syndrome type 2.
I have used certain medications in the last 3 months.
Has had clinically significant body weight change or dieting attempts in the prior 90 days
See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive tirzepatide therapy only

4 weeks

Treatment Period 2

Participants receive combination therapy of bremelanotide, placebo, or tirzepatide

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Bremelanotide
  • Tirzepatide
Trial Overview 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.
Participant Groups
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

Bremelanotide is already approved in United States for the following indications:

🇺🇸
Approved in United States as Vyleesi for:
  • Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women

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Who Is Running the Clinical Trial?

Palatin Technologies, Inc

Lead Sponsor

Trials
12
Recruited
3,000+

Findings from Research

Tirzepatide is a novel medication that acts on both GIP and GLP-1 receptors, enhancing insulin secretion and reducing glucagon levels, which helps improve glycemic control in adults with type 2 diabetes mellitus (T2DM).
It received its first approval in the USA in May 2022 for T2DM treatment and is currently being studied for additional conditions like obesity, heart failure, and non-alcoholic steatohepatitis, indicating its potential for broader therapeutic applications.
Tirzepatide: First Approval.Syed, YY.[2022]
Tirzepatide, a new medication approved by the FDA, acts as an agonist for both GLP-1 and GIP receptors, which helps improve blood sugar control in patients with type II diabetes when combined with diet and exercise.
This drug represents a significant advancement in diabetes management, offering a new approach to treatment by targeting multiple pathways involved in glucose regulation.
Tirzepatide: A New Generation Therapeutic for Diabetes Type 2.Al-Horani, RA., Chedid, M.[2023]
Tirzepatide (Mounjaro™) is a new treatment for type 2 diabetes that acts on both GIP and GLP-1 receptors, showing strong results in lowering blood glucose and promoting weight loss based on evidence from five SURPASS clinical trials.
The safety profile of tirzepatide is similar to that of existing GLP-1 receptor agonists, making it a promising option for early intervention in managing type 2 diabetes.
New Drug: Tirzepatide (Mounjaro™).Gettman, L.[2023]

References

Tirzepatide: First Approval. [2022]
2.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Tirzepatide: A New Generation Therapeutic for Diabetes Type 2. [2023]
New Drug: Tirzepatide (Mounjaro™). [2023]
Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. [2023]
Weight loss efficiency and safety of tirzepatide: A Systematic review. [2023]
Endocrine effects of new bombesin/gastrin-releasing peptide antagonists in rats. [2017]
The design and synthesis of potent, selective benzodiazepine sulfonamide bombesin receptor subtype 3 (BRS-3) agonists with an increased barrier of atropisomerization. [2012]
Radiolabelled peptides for tumour therapy: current status and future directions. Plenary lecture at the EANM 2002. [2018]
Systematic optimization of a lead-structure identities for a selective short peptide agonist for the human orphan receptor BRS-3. [2014]
Identification of a unique ligand which has high affinity for all four bombesin receptor subtypes. [2019]
Tirzepatide, a New Era of Dual-Targeted Treatment for Diabetes and Obesity: A Mini-Review. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Impact of tirzepatide in a patient with type 1 diabetes and obesity: A case report. [2023]
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