Bremelanotide + Tirzepatide for Obesity

(BMT-801 Trial)

Not currently recruiting at 3 trial locations

Overseen By Samantha Wagner

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Palatin Technologies, Inc

Must be taking: Tirzepatide

Must not be taking: Anti-obesity medications

Disqualifiers: Pregnancy, Diabetes, Hypertension, Alcohol dependence, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of combining bremelanotide and tirzepatide to help people with obesity. Researchers aim to determine if these treatments together can reduce weight in individuals with a body mass index (BMI) between 30 and 45, classified as obese. Participants should be willing to self-inject medications and must not have experienced significant weight changes or undergone surgeries affecting weight recently. The study includes different groups: some will receive both treatments, others just one, and some a placebo (a non-active substance) for comparison. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in obesity treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that bremelanotide is generally safe and well-tolerated. In earlier studies, 90% of participants completed the trials and experienced significant weight loss, with no serious safety issues found. Animal studies also showed no harmful effects, indicating good safety prospects.

For tirzepatide, research indicates it is also well-tolerated. Participants who took tirzepatide for up to three years did not report major safety problems. They lost a significant amount of weight, and the treatment helped delay type 2 diabetes.

Early research suggests that using bremelanotide and tirzepatide together is safe. Participants lost more weight compared to those using tirzepatide alone, with no new safety concerns.

Both treatments have demonstrated a strong safety record in earlier research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Bremelanotide and Tirzepatide for obesity because these treatments offer unique approaches compared to traditional options like lifestyle changes, orlistat, and liraglutide. Unlike many existing treatments, Tirzepatide is a dual agonist that targets both GLP-1 and GIP receptors, which may enhance weight loss by regulating appetite and metabolism more effectively. Bremelanotide, on the other hand, is known for its ability to influence the brain's pathways that control hunger. The combination therapy of these two drugs holds promise for a more comprehensive approach to managing obesity by targeting multiple pathways simultaneously, potentially leading to more significant and sustained weight loss.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that bremelanotide, which participants in this trial may receive as monotherapy, can aid in weight loss. One study found that 90% of those using bremelanotide lost more weight than those who did not. Tirzepatide, another treatment option in this trial, has also proven effective for weight loss. In a long-term study, individuals using tirzepatide experienced significant and lasting weight loss. Early findings suggest that combining bremelanotide and tirzepatide, as tested in the combination therapy arm of this trial, may result in greater weight loss than using tirzepatide alone. This combination could offer a more effective approach to treating obesity. ^{1 2 6 7 8}

Who Is on the Research Team?

Robert Jordan

Principal Investigator

Palatin

Are You a Good Fit for This Trial?

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

Have a body mass index (BMI) of 30.0 to 45.0 kg/m^2 at screening

Female subjects must agree not to donate eggs for any purpose

Subjects must have the ability to understand and provide written informed consent

Exclusion Criteria

I have been diagnosed with multiple endocrine neoplasia syndrome type 2.

Has had clinically significant body weight change or dieting attempts in the prior 90 days

Has type 1 diabetes

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Placebo Active Control 1 Intervention

Group II: tirzepatide and bremelanotide Combination Therapy Active Control 2 Interventions

Group III: bremelanotide Monotherapy Placebo Group 1 Intervention

Group IV: tirzepatide Monotherapy Placebo Group 1 Intervention

N=1

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

Who Is Running the Clinical Trial?

Palatin Technologies, Inc

Lead Sponsor

Trials

12

Recruited

3,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: First Approval. Syed, YY.[2022]

The study identified key amino acid side chains in specific peptide agonists that are crucial for activating the human bombesin receptor subtype 3 (BRS-3), which may play a role in obesity and cancer.

A new highly active and selective BRS-3 agonist was developed, reducing the peptide size from 8 or 9 amino acids to a more efficient tripeptide, potentially enhancing its therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic optimization of a lead-structure identities for a selective short peptide agonist for the human orphan receptor BRS-3. Weber, D., Berger, C., Heinrich, T., et al.[2014]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: A New Generation Therapeutic for Diabetes Type 2. Al-Horani, RA., Chedid, M.[2023]

Tirzepatide significantly reduces body weight in patients with type 2 diabetes and obesity, with an average weight loss of -9.81 kg compared to placebo, based on a meta-analysis of 10 studies involving 9,873 patients.

While tirzepatide is effective for weight loss, it has a higher incidence of gastrointestinal side effects compared to placebo, although serious adverse events and hypoglycemia are less common, indicating a need for monitoring these reactions during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss efficiency and safety of tirzepatide: A Systematic review. Lin, F., Yu, B., Ling, B., et al.[2023]

In a systematic review of randomized controlled trials involving 5800 patients, tirzepatide was found to be highly effective for weight loss, with 78.22% achieving at least 5% weight loss and 32.28% achieving at least 15% weight loss.

Tirzepatide demonstrated superior weight loss compared to placebo and semaglutide, with a significant mean weight loss of -12.47 kg at the 5 mg dose, while showing a manageable safety profile with only a slight increase in gastrointestinal adverse events compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. Tan, B., Pan, XH., Chew, HSJ., et al.[2023]

Radiolabelled somatostatin analogues have shown effective therapeutic responses in treating receptor-positive tumors, as demonstrated in preclinical and clinical multicenter studies.

Combining different radionuclides and peptide-based radioligands, such as bombesin and NPY(Y(1)) analogues, is being explored to enhance treatment efficacy for various cancers, including breast and prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiolabelled peptides for tumour therapy: current status and future directions. Plenary lecture at the EANM 2002. de Jong, M., Kwekkeboom, D., Valkema, R., et al.[2018]

In a case study of a 23-year-old female with type 1 diabetes and obesity, the use of tirzepatide led to significant improvements in glycemic control, with her time in range (TIR) increasing from 31% to 61% over 12 weeks.

The patient also experienced a reduction in daily insulin requirements from 81.9 units to 57.6 units, a decrease in hemoglobin A1c from 7.4% to 6.9%, and a weight loss of 7 pounds, suggesting that tirzepatide may be a promising treatment for managing type 1 diabetes in patients with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of tirzepatide in a patient with type 1 diabetes and obesity: A case report. Mendoza, F., Parsiani, R.[2023]

The newly discovered ligand, 125I-[D-Tyr6,betaAla11,Phe13,Nle14]bombesin-(6-1 4), shows high affinity (1-8 nM) for all four bombesin receptor subtypes, making it a valuable tool for pharmacological studies.

This ligand is specific for gastrin-releasing peptide receptors and does not interfere with other receptor types, indicating its potential for targeted research on bombesin receptors, especially the poorly understood BRS-3 receptor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of a unique ligand which has high affinity for all four bombesin receptor subtypes. Pradhan, TK., Katsuno, T., Taylor, JE., et al.[2019]

Tirzepatide, a dual GLP-1 and GIP receptor agonist, has been shown to significantly reduce blood sugar levels, improve insulin sensitivity, and lead to over 20% weight loss, making it a promising treatment for obesity and diabetes.

Approved by the FDA in May 2022, tirzepatide offers a convenient once-weekly subcutaneous injection, leveraging its unique design to enhance its effectiveness and provide a new therapeutic option for managing diabetes and related cardiometabolic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, a New Era of Dual-Targeted Treatment for Diabetes and Obesity: A Mini-Review. Chavda, VP., Ajabiya, J., Teli, D., et al.[2022]

The study identified that certain bombesin/GRP receptor antagonists, particularly RC-3095, effectively inhibit gastrin and glucagon secretion in response to GRP-(14-27), indicating their potential as therapeutic agents in managing endocrine functions.

RC-3095 was shown to completely prevent the suppression of serum growth hormone (GH) induced by GRP-(14-27), suggesting that specific bombesin/GRP receptors play a crucial role in regulating GH release from the pituitary gland.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endocrine effects of new bombesin/gastrin-releasing peptide antagonists in rats. Pinski, J., Yano, T., Groot, K., et al.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Drug: Tirzepatide (Mounjaro™). Gettman, L.[2023]

The study focuses on developing a selective agonist for the bombesin receptor subtype 3 (BRS-3), which is important in managing diabetes and obesity, by modifying the compound MK-7725 to prevent atropisomerization.

By increasing steric bulk at the C-2 position of the compound, the researchers aim to enhance the stability of the agonist, making it more cost-effective for clinical development by reducing the risk of racemization over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The design and synthesis of potent, selective benzodiazepine sulfonamide bombesin receptor subtype 3 (BRS-3) agonists with an increased barrier of atropisomerization. Chobanian, HR., Guo, Y., Liu, P., et al.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9314948/

Effect of bremelanotide on body weight of obese women Results. In Study A, 27 of 30 bremelanotide subjects (90.0%) completed the trial and exhibited a significantly greater reduction in body weight after 16 days ...

2. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/abs/10.1111/dom.14672

Effect of bremelanotide on body weight of obese women: Data ... In Study A, 27 of 30 bremelanotide subjects (90.0%) completed the trial and exhibited a significantly greater reduction in body weight after 16 ...

3. palatin.com palatin.com/press_releases/palatin-initiates-phase-2-clinical-study-of-bremelanotide-for-the-treatment-of-obesity/

Palatin Initiates Phase 2 Clinical Study of Bremelanotide ... The primary endpoint of the trial is to demonstrate the safety and increased efficacy of the co-administration of bremelanotide with tirzepatide ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06565611

NCT06565611 | A Phase 2 Study Evaluating the Co- ... This is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of bremelanotide (BMT) used in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35170192/

Effect of bremelanotide on body weight of obese women Results: In Study A, 27 of 30 bremelanotide subjects (90.0%) completed the trial and exhibited a significantly greater reduction in body weight after 16 days ...

6. palatin.com palatin.com/press_releases/palatin-completes-phase-2-obesity-study-with-mc4r-bremelanotide-plus-glp-1-gip-tirzepatide/

Palatin Completes Phase 2 Obesity Study With MC4R ... Patients underwent multiple assessments of safety and efficacy to help profile the effectiveness of bremelanotide in treating general obesity ...

7. prnewswire.com prnewswire.com/news-releases/palatin-presents-data-at-obesityweek-2025-highlighting-promise-of-melanocortin-based-therapies-for-obesity-302606887.html

Palatin Presents Data at ObesityWeek® 2025 Highlighting ... Encouraging safety and tolerability, with no hERG or Ames assay findings and no toxicity observed in a 28-day non-GLP rat study. "These results ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000MultidisciplineR.pdf

Multi-Discipline Review - accessdata.fda.gov Vyleesi is a drug-device combination product containing the active ingredient bremelanotide. (BMT), a synthetic heptapeptide and ...