A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity

NCT06565611 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: BMT-801
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Obesity

Keywords

Obesity; Tirzepatide; Bremelanotide; BMI

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight between treatment arms

  Percent change in patient weight from baseline (Visit 2/Day 1) to Visit 10 (Day 57) for the BMT/tirzepatide combination group compared to placebo

  Change from the baseline (Visit 2/Day 1) to Visit 10 (Day 57)

Other Outcomes (11)

• Change in Body Weight

  Change from the Visit 2 baseline and Treatment Period 2 baseline (Day 29) to Visit 10 (Day 57)

• Change in Overall Appetite Suppression

  Change from the Visit 2 baseline and Treatment Period 2 baseline (Day 29) to Visit 10 (Day 57)

• Change in Appetite Suppression Subscales

  Change from the Visit 2 baseline and Treatment Period 2 baseline (Day 29) to Visit 10 (Day 57)

Study Arms (4)

tirzepatide and bremelanotide Combination Therapy

ACTIVE COMPARATOR

Drug: bremelanotide; Drug: tirzepatide

tirzepatide Monotherapy

PLACEBO COMPARATOR

N=1

Drug: tirzepatide

bremelanotide Monotherapy

PLACEBO COMPARATOR

Drug: bremelanotide

Placebo

NO INTERVENTION

Interventions

bremelanotide DRUG

bremelanotide (BMT) sterile aqueous solution for subcutaneous injection, provided as autoinjectors containing 0.3 mL volume

bremelanotide Monotherapy; tirzepatide and bremelanotide Combination Therapy

tirzepatide DRUG

tirzepatide (GLP-1/GIP) will be provided in its commercial form for SC injection.

tirzepatide Monotherapy; tirzepatide and bremelanotide Combination Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged between 18-65 years of age, inclusive at the time of consent.
• Have a body mass index (BMI) of 30.0 to 45.0 kg/m\^2 (inclusive) at screening.
• Female subjects must have a negative urine pregnancy test at screening, if of childbearing potential or be of non-childbearing potential. If the urine test is positive or cannot be confirmed as negative, then the subject must have a negative serum pregnancy test (hCG). Non-childbearing potential is defined as (by other than medical reasons):
• Age ≥ 50 years, no menses for at least one year, per subject self-report.
• Documented hysterectomy, bilateral tubal ligation, or bilateral oophorectomy.
• For female subjects who are Women of childbearing potential (WOCBP), subject must agree to abstain from heterosexual intercourse or use a highly effective contraceptive(s) (with a failure rate of \<1% per year), as described in the protocol, during the treatment and follow-up and for at least 90 days after the last dose of bremelanotide. Hormonal-based contraception is to be employed for a minimum of 28 days prior to Day 0. Oral hormonal contraceptives should be combined estrogen and progesterone. If a progesterone-only oral contraceptive is used, then a second method of birth control should be used as well. Acceptable forms of contraception include:
• Surgical sterilization of the subject or male partner;
• FDA- or Health Canada-approved female hormonal contraceptives;
• An IUD;
• Essure® (transcervical sterilization);
• "Double-barrier" contraception defined as:
• condom + spermicide, or
• condom + diaphragm (which is used with a spermicide).
• Female subjects must agree not to donate eggs (ova, oocytes) for any purpose during the treatment and follow-up and for at least 30 days after the last dose of BMT.
• Male subjects must agree to abstain from heterosexual intercourse or use double barrier protection with condom and spermicide with any WOCBP sexual partner from screening and continuing for at least 30 days after the last dose of BMT:

You may not qualify if:

• Females who are pregnant, breastfeeding or plan to become pregnant.
• Have a known allergy or intolerance to Melanocortin peptides.
• Subjects with a positive Serum Antigen/Antibody Hepatitis Panel (Hep B and C) and HIV antibody test Human Immunodeficiency Virus (HIV) antibody.
• Note: subject with positive hepatitis C antibody but negative PCR test for active Hepatitis C viral shedding will be allowed to participate in the study. Subjects with a positive Hepatitis B surface antigen antibody or core antigen antibody will be allowed to participate in the study. Subjects with circulating hepatitis B surface antigen or have a positive PCR test for active hepatitis B virus will NOT be allowed to participate in the study.
• Subjects with active alcohol dependence and/or drug use (with Cannabis exception) as assessed by the Investigator will be excluded from the study.
• Has been on bremelanotide therapy (Vyleesi) within the past 6 months prior to screening date.
• Within the past three month, has used cyclosporine A, adrenocorticotropic hormones, long-term corticosteroids (\> 20 mg qd or its equivalent for \> 3 months), or cytotoxic agents.
• Has had clinically significant body weight change (≥5%) or dieting attempts in the prior 90 days (per subject reported information) and Treatment Period 1.
• Prior obesity or weight loss surgery or presence of gastrointestinal implant or bariatric surgery or other weight loss procedures within 2 years of screening (i.e. liposuction, abdominoplasty, intragastric balloon, cholecystectomy, etc.)
• Has HbA1c ≥ 6.5 % or fasting glucose ≥126.0 mg/dL. (either test can be used to establish eligibility).
• Has type 1 diabetes.
• Has taken any experimental drug or therapy within 28 days / 5 half-lives of trial treatment or concurrently participating in another clinical trial.
• Has a history of clinically significant bradycardia and/or a heart rate less than 50 bpm at screening.
• Has multiple endocrine neoplasia syndrome type 2.
• Plan for blood donations during the study and within 30 days following completion of or early discontinuation from the trial.

Sponsors & Collaborators

• Palatin Technologies, Inc: lead

Study Sites (4)

University Clinical Research-DeLand LLC, d/b/a Accel Research

DeLand, Florida, 32720, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405-5093, United States

Location

Lynn Institute of Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

bremelanotide; Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Robert Jordan

  Palatin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: August 22, 2024
• Study Start: August 5, 2024
• Primary Completion: February 5, 2025
• Study Completion: March 31, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)