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ObesityPhase 2BMT-801NCT06565611

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

A Phase 2 study testing bremelanotide and tirzepatide in people with Obesity, run by Palatin Technologies, Inc at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
bremelanotide and tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
4 sitesUnited States
Study dates
5 Aug 2024to 31 Mar 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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:
  • Alternatively, documented sterilization confirmed by the absence of sperm in the ejaculate or ≥ one-year post-operative from vasectomy.
  • Male subjects must agree not to donate sperm for at least 30 days after the last dose of BMT.
  • Subjects must be willing to self-inject.
  • Subjects must have the ability to complete the study in compliance with the protocol and all instructions.
  • Subjects must have the ability to understand and provide written informed consent.

Who cannot join

  • 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.
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  • 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.
  • 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).
  • 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.
  • Planned bariatric surgery or planned major surgeries during the study time period.
  • Has personal or family history of MEN 2 syndromes or Medullary Thyroid Cancer.
  • Prior hypersensitivity to tirzepatide component.
  • Has hypertension (by medical history or by screening vital signs) and/or known cardiovascular disease.
  • Note: If subject presents at screening with elevated blood pressure and no supporting evidence of hypertension; subject may wait approximately 1 hour to have blood pressure rechecked; if readings are still elevated, subject may return to the site approximately 24 hours later to have blood pressure rechecked.
  • Is taking concomitant oral drugs that are dependent on threshold concentrations for efficacy (e.g., antibiotics) since bremelanotide slows gastric emptying and thus has the potential to reduce the rate and extent of absorption of concomitantly administered oral medications
  • Has a diagnosis of type 2 diabetes
  • Has Clinically significant ECG abnormalities on ECG at Screening

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Lynn Institute of Chattanooga

    Chattanooga, Tennessee, 37404

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

    DeLand, Florida, 32720

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405-5093

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

Other trials in United States

About this study

Official title: 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

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).

Read the 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.
Conditions
Obesity
Being tested
bremelanotide, tirzepatide
Keywords
Obesity, Tirzepatide, Bremelanotide, BMI
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bremelanotideDrug

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

  • tirzepatideDrug

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

Study groups in NCT06565611
Study groupRoleWhat they receive
tirzepatide and bremelanotide Combination TherapyActive comparatorNot described
Receives: Drug: bremelanotide; Drug: tirzepatide
tirzepatide MonotherapyPlacebo comparatorN=1
Receives: Drug: tirzepatide
bremelanotide MonotherapyPlacebo comparatorNot described
Receives: Drug: bremelanotide
PlaceboNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2024
  2. Study start5 Aug 2024
  3. Primary completion5 Feb 2025
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06565611
Sponsor's protocol ID
BMT-801
Acronym
BMT-801
Status last verified
Mar 2025
First submitted
5 Jun 2024
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bremelanotide and tirzepatide in people with Obesity, run by Palatin Technologies, Inc at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in body weight between treatment arms (time frame: Change from the baseline (Visit 2/Day 1) to Visit 10 (Day 57)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06565611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.

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BMT-801 Clinical Trial NCT06565611 | AzTrials