Metabolic SyndromeEarly Phase 1THCVNCT05574049
Weight Loss, Blood Sugar and Blood Lipid Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips
A Early Phase 1 study testing Tetrahydrocannabivarin in people with Metabolic Syndrome and Morbid Obesity, run by Medical Life Care Planners, LLC at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the efficacy of two different daily doses of tetrahydrocannabivarin impregnated mouth strips in healthy non-diabetic obese adults. The main questions to answer are: Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Morbid Obesity, Hypercholesterolemia
- What is being tested?
- Tetrahydrocannabivarin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 4 May 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults who met the clinical criteria for obesity (BMI ≥ 30) without comorbid diabetes or cardiovascular disease were selected for this study.
Who cannot join
- Under age 18 BMI less than 30 presence of diabetes or cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight Loss and Therapeutic Metablic Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips
The goal of this clinical trial is to compare the efficacy of two different daily doses of tetrahydrocannabivarin impregnated mouth strips in healthy non-diabetic obese adults. The main questions to answer are:
- Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and blood glucose levels?
- Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and blood glucose levels?
- Is one dose better than the other dose?
Participants will take either the low dose, high dose or placebo dose daily for ninety days and have physical measurements and blood tests obtained at the beginning and the end of the study.
Read the detailed description
Fifty-six adults who met the clinical criteria for obesity (BMI ≥ 30) without comorbid diabetes or cardiovascular disease will be selected for this study. Social media outreach and advertising will be used to identify potential subjects. Prior to starting the study, all subjects will undergo an entrance examination by a blinded independent physician to confirm that they did not have diabetes, active cardiovascular disease, or other confounding health conditions. Initial and final biometric measurements will be taken to include blood pressure, blood oxygen, temperature, height, weight, and abdominal girth. Due to the natural fluctuations in weight, abdominal girth and blood pressure that tend to occur throughout the menstrual cycle, those study participants with active menstrual periods will be scheduled to have their ending biometrics taken during the same phase of their menstrual cycle as when they had their initial biometrics taken, approximately 90 days later. Fasting bloodwork will include a lipid profile, blood sugar, HgbA1c, liver and kidney function studies. LabCorp Inc. will be used for all blood testing.
Each subject will assigned at random to one of three groups: Group A (single dose group), Group B (double dose group,) and Group P (placebo/control group). Subjects will be provided with a 90-day supply of their respective dose (based on group assignment), and instructed to take their assigned dose by mouth, once per day in the morning on an empty stomach. All subjects will be asked to agreed from the outset to refrain from the use of cannabis, CBD, or other hemp-related products throughout the duration of the study. Subjects will be advised to make no changes in their diet or exercise routines.
Each subject will be sent a daily reminder via text message when it was time to take their dose, and was asked to reply with confirmation once they had taken their dose. Additionally, they will be invited to provide feedback on any adverse effects or questions.
- Being tested
- Tetrahydrocannabivarin, Placebo
- Keywords
- tetrahydrocannabivarin, cannabidiol, metabolic syndrome, endocannabinoid system, cannabinoid one receptor
- Medical subject headings
- Metabolic Syndrome, Obesity, Morbid, Hypercholesterolemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetrahydrocannabivarinDrug
Also called THCV
The subjects will take once daily oromucosal strip with intervention drug for 90 days.
PlaceboOther
Also called Plain mucoadhesive mouth strip
The subjects will take once daily oromucosal strip with no drug on it for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Single Dose | Active comparator | Once daily mouth strip containing 8mg of THCV and 10mg of CBD Receives: Drug: Tetrahydrocannabivarin; Other: Placebo |
| Double Dose | Active comparator | Once daily mouth strip containing 16mg of THCV and 20mg of CBD Receives: Drug: Tetrahydrocannabivarin; Other: Placebo |
| Placebo | Placebo comparator | Once daily mouth strip containing nothing Receives: Drug: Tetrahydrocannabivarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Change in body weight measured in kilograms
Measured: 90 days
Decreased abdominal girth
Change in abdominal girth measures in centimeters
Measured: 90 days
Systolic and diastolic blood pressure
Changes in systolic and diastolic blood pressure
Measured: 90 days
Secondary outcomes (2)
Aspartate Aminotransferase (AST) changes
Change in AST level in blood tests
Measured: 90 days
Alanine Transaminase (ALT) changes
Change in ALT level in blood tests
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start4 Jan 2022
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be divided into three groups for daily doses. One group with get single dose (8mg THCV/10mg CBD), one group will get double dose (16mg THCV/20mg CBD) and the placebo group will get mouth strip only.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Life Care Planners, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574049
- Sponsor's protocol ID
- Weight Loss with THCV
- Acronym
- THCV
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and Therapeutic Metablic Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips
- ClinicalTrials.gov ID
- NCT05574049
- Acronym / sponsor ID
- THCV / Weight Loss with THCV
- Keywords
- tetrahydrocannabivarin, cannabidiol, metabolic syndrome, endocannabinoid system, cannabinoid one receptor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Medical Life Care Planners, LLCUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the efficacy of two different daily doses of tetrahydrocannabivarin impregnated mouth strips in healthy non-diabetic obese adults. The main questions to answer are:
- Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and blood glucose levels?
- Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and blood glucose levels?
- Is one dose better than the other dose?
Participants will take either the low dose, high dose or placebo dose daily for ninety days and have physical measurements and blood tests obtained at the beginning and the end of the study.
Detailed description
Fifty-six adults who met the clinical criteria for obesity (BMI ≥ 30) without comorbid diabetes or cardiovascular disease will be selected for this study. Social media outreach and advertising will be used to identify potential subjects. Prior to starting the study, all subjects will undergo an entrance examination by a blinded independent physician to confirm that they did not have diabetes, active cardiovascular disease, or other confounding health conditions. Initial and final biometric measurements will be taken to include blood pressure, blood oxygen, temperature, height, weight, and abdominal girth. Due to the natural fluctuations in weight, abdominal girth and blood pressure that tend to occur throughout the menstrual cycle, those study participants with active menstrual periods will be scheduled to have their ending biometrics taken during the same phase of their menstrual cycle as when they had their initial biometrics taken, approximately 90 days later. Fasting bloodwork will include a lipid profile, blood sugar, HgbA1c, liver and kidney function studies. LabCorp Inc. will be used for all blood testing.
Each subject will assigned at random to one of three groups: Group A (single dose group), Group B (double dose group,) and Group P (placebo/control group). Subjects will be provided with a 90-day supply of their respective dose (based on group assignment), and instructed to take their assigned dose by mouth, once per day in the morning on an empty stomach. All subjects will be asked to agreed from the outset to refrain from the use of cannabis, CBD, or other hemp-related products throughout the duration of the study. Subjects will be advised to make no changes in their diet or exercise routines.
Each subject will be sent a daily reminder via text message when it was time to take their dose, and was asked to reply with confirmation once they had taken their dose. Additionally, they will be invited to provide feedback on any adverse effects or questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will be divided into three groups for daily doses. One group with get single dose (8mg THCV/10mg CBD), one group will get double dose (16mg THCV/20mg CBD) and the placebo group will get mouth strip only.
| Arm | Type | Receives |
|---|---|---|
| Single Dose | Active comparator | Drug: Tetrahydrocannabivarin, Other: PlaceboOnce daily mouth strip containing 8mg of THCV and 10mg of CBD |
| Double Dose | Active comparator | Drug: Tetrahydrocannabivarin, Other: PlaceboOnce daily mouth strip containing 16mg of THCV and 20mg of CBD |
| Placebo | Placebo comparator | Drug: TetrahydrocannabivarinOnce daily mouth strip containing nothing |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults who met the clinical criteria for obesity (BMI ≥ 30) without comorbid diabetes or cardiovascular disease were selected for this study.
Key exclusion criteria (1 listed)
- Under age 18 BMI less than 30 presence of diabetes or cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetrahydrocannabivarinAlso: THCVThe subjects will take once daily oromucosal strip with intervention drug for 90 days. | Drug | Double Dose, Placebo, Single Dose |
| PlaceboAlso: Plain mucoadhesive mouth stripThe subjects will take once daily oromucosal strip with no drug on it for 90 days | Other | Double Dose, Single Dose |
Primary outcome
Weight Loss
Time frame: 90 days
Change in body weight measured in kilograms
Decreased abdominal girth
Time frame: 90 days
Change in abdominal girth measures in centimeters
Systolic and diastolic blood pressure
Time frame: 90 days
Changes in systolic and diastolic blood pressure
2 secondary outcomes
Aspartate Aminotransferase (AST) changes
Time frame: 90 days
Alanine Transaminase (ALT) changes
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tetrahydrocannabivarin in people with Metabolic Syndrome and Morbid Obesity, run by Medical Life Care Planners, LLC at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight Loss (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2022.