A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity

Palatin Technologies, Inc4 sites in 1 country108 target enrollmentAugust 5, 2024

ConditionsObesity

Interventionsbremelanotide tirzepatide

Drugsbremelanotide tirzepatide

Overview

Phase: Phase 2
Intervention: bremelanotide
Conditions: Obesity
Sponsor: Palatin Technologies, Inc
Enrollment: 108
Locations: 4
Primary Endpoint: Percent change in body weight between treatment arms
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

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).

Detailed Description

A total of approximately 108 subjects at approximately five (5) centers within the United States (US), will be enrolled into the study for 8 weeks of treatment. Subjects who provide written informed consent and meet all initial eligibility criteria will enter into Screening. The subjects' historical and current medical data will be collected, reviewed, and recorded to be used as baseline values. Enrolled subjects will begin the study and go through 2 treatment periods: * "Treatment Period 1" - 4 weeks of tirzepatide therapy only * "Treatment Period 2" - 4 weeks of combination therapy of bremelanotide, Placebo, or tirzepatide therapy.

Registry

clinicaltrials.gov

Start Date

August 5, 2024

End Date

March 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Palatin Technologies, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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;
•Essure® (transcervical sterilization);

Exclusion Criteria

•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.
•Have significant medical illnesses that cannot be adequately controlled with appropriate therapy and may obscure toxicity, dangerously alter drug metabolism, or compromise the subject's ability to participate in the trial, as determined by the Investigator, such as endocrinologic disorders accounting for obesity such as Cushing Disease, syndrome or monogenic obesity and exclusions of organ transplant recipients, those on wait lists, or those on anti-rejection medication as the potential effect on gastric emptying effecting pharmacokinetics.
•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
•Use of Anti-Obesity Medication (AOM) within a 90-day period prior to screening (Note: subjects who have taken or are still taking tirzepatide may participate in study if exclusion criteria #8 has not been met. AOM medications will also include medications that are being used off-label for weight loss).