ObesityPhase 4BIMNCT02237079
Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
A Phase 4 study testing Bazedoxifene/Conjugated Estrogens (BZA/CE) in people with Obesity and Glucose Homeostasis, run by Tulane University Health Sciences Center at 1 site in United States.
Trial summary
The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Obesity, Glucose Homeostasis, Postmenopausal Symptoms
- What is being tested?
- Bazedoxifene/Conjugated Estrogens (BZA/CE)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Apr 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Post-menopausal women (<5y since final menstrual period) with age between 50-60y
- Symptomatic (hot flashes, vaginal dryness) or asymptomatic
- BMI 26-45 kg/m2 (Overweight, Obesity I and Obesity II)
- Fasting glucose <125mg/dl
- Triglycerides <200mg/dl
- Normal mammogram within past 12 months
- Physician clearance
Who cannot join
- Amenorrhea from other causes (Hyperandrogenemia and anovulation)
- type 2 and type 1 diabetes
- Medications: diabetes or diabetic drugs, dyslipidemia, estrogen/progestin therapy, antidepressants and antipsychotics, antiretroviral (HIV), oral steroids, weight loss drugs
- ≤ 3 month washout of birth control pill (often prescribed for postmenopausal symptoms)
- Hysterectomy (partial or complete)
- Contraindications to estrogen treatment (unusual vaginal bleeding, blot clots, hepatic disease, bleeding disorder, past/present history of breast or uterine cancer, pregnant, breastfeeding)
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University Clinical Translational Unit
New Orleans, Louisiana, 70112
About this study
The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. The recruitment will be performed at Tulane Health Sciences Center.
- Conditions
- Obesity, Glucose Homeostasis, Postmenopausal Symptoms
- Being tested
- Bazedoxifene/Conjugated Estrogens (BZA/CE), Placebo Oral Tablet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bazedoxifene/Conjugated Estrogens (BZA/CE)Drug
Also called DUAVEE
Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
Placebo Oral TabletDrug
Daily placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Bazedoxifene/Conjugated Estrogens (BZA/CE) | Experimental | Participants assigned to BZA/CE will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg. BZA/CE (bazedoxifene/conjugated estrogens) tablets, 0.45 mg/20 mg are oval, biconvex, pink tablets, branded with "0.45/20" in black ink on one side. The recommended and only FDA approved dosage is one BZA/CE tablet daily, taken without regard to meals. Tablets should be swallowed whole. If a dose of BZA/CE is missed, participants will be instructed to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time. The dose is one tablet per day independent of weight and fat mass. Participants will be provided with information about BZA/CE and its potential side effects and contraindications. Receives: Drug: Bazedoxifene/Conjugated Estrogens (BZA/CE) |
| Placebo | Placebo comparator | Participants assigned to placebo will receive a daily tablet that matches the BZA/CE to maintain the blind. Placebo tablets, 0.45 mg/20 mg are oval, biconvex, pink tablets, branded with "0.45/20" in black ink on one side. Also to assure the blind is maintain, participants in the placebo group will be given the same instructions for taking the study medication.Tablets should be swallowed whole. If a dose, participants will be instructed to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time. The dose is one tablet per day independent of weight and fat mass. Participants will be provided with information about BZA/CE and its potential side effects and contraindications, again to maintain the blind. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index
Body composition will be assessed through change in body mass index at baseline and at 3 months post-treatment.
Measured: Change at 3 months from baseline
Effect of CE/BZA on Body Composition Using Waist-to-hip Ratio
Body composition will be assessed through change in waist-to-hip ratio at baseline and at 3 months post-treatment.
Measured: Change at 3 months from baseline
Change in Body Composition Using Dual-energy X-ray Absorptiometry (DXA)
Dual-Energy X-ray Absorptiometry was used to assess body composition. DXA uses an x-ray technique to look at the density of the body and can then estimate the amount of lean muscle mass and fat tissue. Body composition will be assessed through change in DXA body composition at baseline and at 3 months post-treatment.
Measured: Change at 3 months from baseline
Change in Acute Insulin Response to Glucose (AIRg)
This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in acute insulin response to glucose. IVGTT data derived by MINMOD Millennium software. MINMOD: a computer program to calculate insulin sensitivity and pancreatic responsivity from the frequently sampled intravenous glucose tolerance test. Acute Insulin Response (AIRg) to Intravenous Glucose is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection following glucose administration. A low AIRg indicates decreased ability of the pancreas to secrete insulin.
Measured: Change at 3 months from baseline
Change in Basal Glucose Concentration (Gb)
This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in basal glucose concentration. IVGTT data derived by MINMOD Millennium software.
Measured: Change at 3 months from baseline
Change in Disposition Index (DI)
Disposition index (DI) is the product of insulin sensitivity times the amount of insulin secreted in response to blood glucose levels. DI is commonly used as a measure of β-cell function. This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in disposition index (DI). IVGTT data derived by MINMOD Millennium software. DI is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. DI is the product of insulin sensitivity and the amount of insulin secreted in response to blood glucose levels. Disposition index is used as a measure of beta cell function and the ability of the body to dispose of a glucose load. A low DI is indicative of a higher risk of developing diabetes.
Measured: Change at 3 months from baseline
Change in Insulin Sensitivity (SI) Index
SI indicates the net capacity for insulin to promote the disposal of glucose and to inhibit the endogenous production of glucose. This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in insulin sensitivity (SI) index. IVGTT data derived by MINMOD Millennium software. SI is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. SI is a measure of tissue response to circulating insulin in the blood following glucose injection. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity.
Measured: Change at 3 months from baseline
Change in Homeostatic Model Assessment (HOMA) β-cell Function
The homeostasis model assessment of β-cell function (HOMA-β) is an index of insulin secretory function derived from fasting plasma glucose and insulin concentrations. This will be assessed at baseline and 3 months to measure the change in Homeostatic model assessment (HOMA) β-cell function. (HOMA) β-cell function is a method used to quantify beta-cell function from fasting blood samples of insulin and glucose. Normal levels for (HOMA) β-cell function is 107 or more. Lower numbers mean higher risk of developing diabetes.
Measured: Change at 3 months from baseline
Change in Homeostatic Model Assessment (HOMA) Insulin Resistance (IR)
Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. This will be assessed at baseline and 3 months to measure the change in Homeostatic model assessment (HOMA) insulin resistance. HOMA IR is a method used to quantify insulin resistance from fasting blood samples of insulin and glucose. Normal levels for HOMA-IR is less than 2.0. Higher levels mean higher risk for developing diabetes.
Measured: Change at 3 months from baseline
Change in Fasting Insulin Clearance (FIC)
This will be assessed at baseline and 3 months to measure the change in fasting insulin clearance (FIC). FIC derived from fasting C-peptide to insulin ratio.
Measured: Change at 3 months from baseline
Change in Glucose-stimulated Insulin Clearance (GSIC)
This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in glucose-stimulated insulin clearance (GSIC). GSIC derived from molar ratio of C-peptide to insulin area under curve (AUC) over first 20 min of IVGTT.
Measured: Change at 3 months from baseline
Secondary outcomes (6)
Measure Change in Serum Biomarkers Panel 1
Systematic inflammation will be measured through change in serum biomarkers (Leptin, Lipocalin 2 (LCN2), plasminogen activator inhibitor-1 (PAI-1), Intact OCN) taken at baseline and 3 months.
Measured: Change at 3 months from baseline
Measure Change in Serum Biomarkers Panel 2
Systematic inflammation will be measured through change in serum biomarkers (Adiponectin, RBP4) taken at baseline and 3 months.
Measured: Change at 3 months from baseline
Measure Change in Leptin:Adiponectin Ratio (LAR)
Systematic inflammation will be measured through change in leptin:adiponectin ratio (LAR) taken at baseline and 3 months.
Measured: Change at 3 months from baseline
Measure Change in Fibroblast Growth Factor-21 (FGF-21)
Systematic inflammation will be measured through change in Fibroblast growth factor-21 (FGF-21) taken at baseline and 3 months.
Measured: Change at 3 months from baseline
Measure Change in C-Reactive Protein (CRP)
Systematic inflammation will be measured through change in C-Reactive Protein (CRP) taken at baseline and 3 months.
Measured: Change at 3 months from baseline
Measure Change in Thiobarbituric Acid Reactive Substance (TBARS)
Systematic inflammation will be measured through change in Thiobarbituric acid reactive substance (TBARS) taken at baseline and 3 months.
Measured: Change at 3 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies 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
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franck Mauvais-Jarvis, Tulane University Health Sciences Center
- Investigators
- Franck Mauvais-Jarvis, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237079
- Sponsor's protocol ID
- WI190523
- Acronym
- BIM
- Status last verified
- May 2023
- First submitted
- 26 Aug 2014
- Last updated
- 26 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: At this time there is no plan to share individual participant data (IPD)
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
- ClinicalTrials.gov ID
- NCT02237079
- Acronym / sponsor ID
- BIM / WI190523
- Conditions
- Obesity, Glucose Homeostasis, Postmenopausal Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Tulane University Health Sciences CenterUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Posted 26 Jun 2023
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 pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. The recruitment will be performed at Tulane Health Sciences Center.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bazedoxifene/Conjugated Estrogens (BZA/CE) | Experimental | Drug: Bazedoxifene/Conjugated Estrogens (BZA/CE)Participants assigned to BZA/CE will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg. BZA/CE (bazedoxifene/conjugated estrogens) tablets, 0.45 mg/20 mg are oval, biconvex, pink tablets, branded with "0.45/20" in black ink on one side. The recommended and only FDA approved dosage is one BZA/CE tablet daily, taken without regard to meals. Tablets should be swallowed whole. If a dose of BZA/CE is missed, participants will be instructed to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time. The dose is one tablet per day independent of weight and fat mass. Participants will be provided with information about BZA/CE and its potential side effects and contraindications. |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletParticipants assigned to placebo will receive a daily tablet that matches the BZA/CE to maintain the blind. Placebo tablets, 0.45 mg/20 mg are oval, biconvex, pink tablets, branded with "0.45/20" in black ink on one side. Also to assure the blind is maintain, participants in the placebo group will be given the same instructions for taking the study medication.Tablets should be swallowed whole. If a dose, participants will be instructed to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time. The dose is one tablet per day independent of weight and fat mass. Participants will be provided with information about BZA/CE and its potential side effects and contraindications, again to maintain the blind. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Post-menopausal women (<5y since final menstrual period) with age between 50-60y
- Symptomatic (hot flashes, vaginal dryness) or asymptomatic
- BMI 26-45 kg/m2 (Overweight, Obesity I and Obesity II)
- Fasting glucose <125mg/dl
- Triglycerides <200mg/dl
Key exclusion criteria (6 listed)
- Amenorrhea from other causes (Hyperandrogenemia and anovulation)
- type 2 and type 1 diabetes
- Medications: diabetes or diabetic drugs, dyslipidemia, estrogen/progestin therapy, antidepressants and antipsychotics, antiretroviral (HIV), oral steroids, weight loss drugs
- ≤ 3 month washout of birth control pill (often prescribed for postmenopausal symptoms)
- Hysterectomy (partial or complete)
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 |
|---|---|---|
| Bazedoxifene/Conjugated Estrogens (BZA/CE)Also: DUAVEEDaily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg. | Drug | Bazedoxifene/Conjugated Estrogens (BZA/CE) |
| Placebo Oral TabletDaily placebo tablet | Drug | Placebo |
Primary outcome
Change in Body Mass Index
Time frame: Change at 3 months from baseline
Body composition will be assessed through change in body mass index at baseline and at 3 months post-treatment.
Effect of CE/BZA on Body Composition Using Waist-to-hip Ratio
Time frame: Change at 3 months from baseline
Body composition will be assessed through change in waist-to-hip ratio at baseline and at 3 months post-treatment.
Change in Body Composition Using Dual-energy X-ray Absorptiometry (DXA)
Time frame: Change at 3 months from baseline
Dual-Energy X-ray Absorptiometry was used to assess body composition. DXA uses an x-ray technique to look at the density of the body and can then estimate the amount of lean muscle mass and fat tissue. Body composition will be assessed through change in DXA body composition at baseline and at 3 months post-treatment.
Change in Acute Insulin Response to Glucose (AIRg)
Time frame: Change at 3 months from baseline
This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in acute insulin response to glucose. IVGTT data derived by MINMOD Millennium software. MINMOD: a computer program to calculate insulin sensitivity and pancreatic responsivity from the frequently sampled intravenous glucose tolerance test. Acute Insulin Response (AIRg) to Intravenous Glucose is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection following glucose administration. A low AIRg indicates decreased ability of the pancreas to secrete insulin.
Change in Basal Glucose Concentration (Gb)
Time frame: Change at 3 months from baseline
This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in basal glucose concentration. IVGTT data derived by MINMOD Millennium software.
Change in Disposition Index (DI)
Time frame: Change at 3 months from baseline
Disposition index (DI) is the product of insulin sensitivity times the amount of insulin secreted in response to blood glucose levels. DI is commonly used as a measure of β-cell function. This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in disposition index (DI). IVGTT data derived by MINMOD Millennium software. DI is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. DI is the product of insulin sensitivity and the amount of insulin secreted in response to blood glucose levels. Disposition index is used as a measure of beta cell function and the ability of the body to dispose of a glucose load. A low DI is indicative of a higher risk of developing diabetes.
Change in Insulin Sensitivity (SI) Index
Time frame: Change at 3 months from baseline
SI indicates the net capacity for insulin to promote the disposal of glucose and to inhibit the endogenous production of glucose. This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in insulin sensitivity (SI) index. IVGTT data derived by MINMOD Millennium software. SI is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. SI is a measure of tissue response to circulating insulin in the blood following glucose injection. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity.
Change in Homeostatic Model Assessment (HOMA) β-cell Function
Time frame: Change at 3 months from baseline
The homeostasis model assessment of β-cell function (HOMA-β) is an index of insulin secretory function derived from fasting plasma glucose and insulin concentrations. This will be assessed at baseline and 3 months to measure the change in Homeostatic model assessment (HOMA) β-cell function. (HOMA) β-cell function is a method used to quantify beta-cell function from fasting blood samples of insulin and glucose. Normal levels for (HOMA) β-cell function is 107 or more. Lower numbers mean higher risk of developing diabetes.
Change in Homeostatic Model Assessment (HOMA) Insulin Resistance (IR)
Time frame: Change at 3 months from baseline
Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. This will be assessed at baseline and 3 months to measure the change in Homeostatic model assessment (HOMA) insulin resistance. HOMA IR is a method used to quantify insulin resistance from fasting blood samples of insulin and glucose. Normal levels for HOMA-IR is less than 2.0. Higher levels mean higher risk for developing diabetes.
Change in Fasting Insulin Clearance (FIC)
Time frame: Change at 3 months from baseline
This will be assessed at baseline and 3 months to measure the change in fasting insulin clearance (FIC). FIC derived from fasting C-peptide to insulin ratio.
Change in Glucose-stimulated Insulin Clearance (GSIC)
Time frame: Change at 3 months from baseline
This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in glucose-stimulated insulin clearance (GSIC). GSIC derived from molar ratio of C-peptide to insulin area under curve (AUC) over first 20 min of IVGTT.
6 secondary outcomes
Measure Change in Serum Biomarkers Panel 1
Time frame: Change at 3 months from baseline
Measure Change in Serum Biomarkers Panel 2
Time frame: Change at 3 months from baseline
Measure Change in Leptin:Adiponectin Ratio (LAR)
Time frame: Change at 3 months from baseline
Measure Change in Fibroblast Growth Factor-21 (FGF-21)
Time frame: Change at 3 months from baseline
Measure Change in C-Reactive Protein (CRP)
Time frame: Change at 3 months from baseline
Measure Change in Thiobarbituric Acid Reactive Substance (TBARS)
Time frame: Change at 3 months from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. At this time there is no plan to share individual participant data (IPD)
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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.
Franck Mauvais-Jarvis, MD principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bazedoxifene/Conjugated Estrogens (BZA/CE) in people with Obesity and Glucose Homeostasis, run by Tulane University Health Sciences Center 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 7 inclusion and 6 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 26 Jun 2023. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Body Mass Index (time frame: Change at 3 months from baseline). The study lists 11 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 26 Jun 2023.