HivPhase 4META-DNCT05289986
The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients
A Phase 4 study testing DELSTRIGO 100Mg-300Mg-300Mg Tablet in people with Hiv, run by Chelsea and Westminster NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
This is an open label, randomised, two-arm switch study over 48 weeks in which virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv
- What is being tested?
- DELSTRIGO 100Mg-300Mg-300Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 21 Nov 2023to 21 Nov 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infected, 18 years or older
- On stable \& suppressive triple cART containing ABA/3TC or TAF/FTC plus dolutegravir or bictegravir for at least 6 months
- No evidence of resistance to TDF, 3TC, or DOR
- No laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators
- Women who are of childbearing potential and sexually active need to use the hormonal contraceptive methods, associated with inhibition of ovulation, listed in the protocol:
- Implant
Show all 10Show fewer
- Depot injection
- Intra-uterine device or system
- Oral hormonal contraception A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- Men who are sexually active and have partners who are women of childbearing potential must be using an adequate method of contraception to avoid pregnancy (male condom or sterilisation confirmed prior to the subject's entry into the study)
Who cannot join
- History of virological failure on an NNRTI in absence of a post-failure genotypic resistance test proving absence of resistance to DOR
- Concomitant medication contra-indicated with TDF, FTC or DOR
- Haemoglobin <9 g/dL
- Platelets <80,000/mm3
- Creatinine clearance <50 mL/min
- AST or ALT ≥5N
Show all 14Show fewer
- Acute Hepatitis A infection.
- Concomitant DAA for anti-HCV therapy
- Known acute or chronic viral hepatitis B or C.
- o Individuals with positive anti-HCV results, but with HCV RNA not detected may be included on the trial.
- Pregnant or breastfeeding women, or individuals actively trying to conceive
- History of osteoporosis or bone fractures/loss
- Hypersensitivity to the active substance or to any of the excipients in tenofovir disoproxil fumarate, lamivudine and/or doravirine formulations
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Chelsea and Westminster Hospital NHS Foundation Trust
London, London, SW10 9NH
Mortimer Market Centres
London, London, WC1E6JB
About this study
Official title: Switch From Stable cART Containing ABA/3TC or TAF/FTC Plus Dolutegravir or Bictegravir to TDF/3TC/Doravirine in People Living With HIV: Impact on Lipids, Body Composition, Insulin Sensitivity, Neuroendocrine Function and Inflammation Markers
This is an open label, randomised, two-arm switch study over 48 weeks in which virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period.
If patients withdraw or are withdrawn from the study treatment prematurely, an early termination visit (ETV) should occur within 30 days post withdrawal.
The hypothesis of the study is that a switch to Delstrigo, which is a combination of tenofovir disoproxil, lamivudine and doravirine (TDF/3TC/DOR) has a favourable impact on lipid metabolism, glucose, weight, body composition and hepatic steatosis.
Read the detailed description
Open-label, 2 arm, multi-centre, non-inferiority switch study.
Sample size: 60 participants
Participant population: HIV-1 infected patients on stable and suppressive triple cART.
IMP: Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine
- TDF/3TC/DOR)
Study setting: Patients will be identified through HIV clinic visits by their direct study medical care team and visits will be captured on a participant-screening log. A Trial Management Team will facilitate the project and liaise with participating sites in study set-up and progress.
Dose and Route of Administration:
Experimental arm (baseline visit switch group, N=30): One DOR/TDF/3TC tablet taken orally once daily for 48 weeks.
Control arm (deferred switch group, N=30): Participants will continue their current triple cART regimen for 24 weeks, and then switched to taking one TDF/3TC/DOR tablet orally once daily (24 -48 weeks).
Primary Objective To quantify the effect on lipid profile (change from baseline in total fasting cholesterol to Week 24) of switching from suppressive, stable cART containing ABA/3TC or TAF/FTC plus dolutegravir or bictegravir to Delstrigo (TDF/3TC/DOR) in HIV positive patients.
Secondary Objectives
To investigate the effect of switch on:
- Body composition changes when measured by Total Body DXA at week 24 and 48 and by waist circumference
- Change in insulin sensitivity from baseline to week 24 and 48 by HOMA-IR (glucose \& insulin levels)
- PBMC cholesterol and cholesteryl levels
- Adipocytokines by assessing adiponectin, leptin
- Pituitary hormones (TSH, LH, FSH, IGF-1, Testosterone)
- Estimated cardiovascular risk (QRISK3 and D:A:D equations)
- Hepatic steatosis and fibrosis by transient elastography-CAP (FibroScan® with the CAP probe)
- Dietary, Quality of Life (EuroQoL), and Sleep quality (Pittsburgh Sleep Quality Index) Questionnaires
- Renal safety by uPCR, eGFR Potential Exploratory Objectives Platelet aggregation \& endothelial markers, metabolomics
- Conditions
- Hiv
- Being tested
- DELSTRIGO 100Mg-300Mg-300Mg Tablet
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DELSTRIGO 100Mg-300Mg-300Mg TabletDrug
Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine
- TDF/3TC/DOR)
| Study group | Role | What they receive |
|---|---|---|
| immediate switch arm | Experimental | Experimental arm (baseline visit switch group, N=30): One DOR/TDF/3TC tablet taken orally once daily for 48 weeks.
Virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period. Receives: Drug: DELSTRIGO 100Mg-300Mg-300Mg Tablet |
| delayed switch arm | Active comparator | Control arm (deferred switch group, N=30): Participants will continue their current triple cART regimen for 24 weeks, and then switched to taking one TDF/3TC/DOR tablet orally once daily (24 -48 weeks).
Virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period. Receives: Drug: DELSTRIGO 100Mg-300Mg-300Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Quantify the Effect on Lipid Profile
To quantify the effect on lipid profile (change from baseline in total fasting cholesterol to Week 24) of switching from suppressive, stable cART containing ABA/3TC or TAF/FTC plus dolutegravir or bictegravir to Delstrigo (TDF/3TC/DOR) in HIV positive patients.
Measured: 24 weeks
Secondary outcomes (15)
Percentage of Patients With Treatment-related Adverse Events by Week 48
Percentage of patients with treatment-related adverse events by week 48
Measured: 48 weeks
Median Change in Body Fat Content (g) Measured by Total Body Dexa at Week 24 and 48
Median change in body fat content (g) measured by Total body dexa at week 24 and 48
Measured: 48 weeks
Body Composition Changes When Measured by Waist Circumference at Week 24 and 48
Body composition changes when measured by waist circumference at week 24 and 48
Measured: 48 weeks
Change in Insulin Sensitivity From Baseline to Week 24 and 48 by HOMA-IR (Glucose & Insulin Levels)
HOMA-IR is calculated by glucose \& insulin levels and provides a single unit of measure
Measured: 48 weeks
PBMC Cholesterol and Cholesteryl Levels
PBMC cholesterol and cholesteryl levels
Measured: 48 weeks
Adipocytokines by Assessing Adiponectin, Leptin
Adipocytokines by assessing adiponectin, leptin
Measured: 48 weeks
Pituitary Hormones (TSH, LH, FSH, IGF-1, Testosterone)
Pituitary hormones (TSH, LH, FSH, IGF-1, Testosterone)
Measured: 48 weeks
Estimated Cardiovascular Risk (QRISK3 Equation)
Estimated cardiovascular risk (QRISK3 equation)
Measured: 48 weeks
Estimated Cardiovascular Risk (D:A:D Equation)
Estimated cardiovascular risk (D:A:D equation)
Measured: 48 weeks
Hepatic Steatosis and Fibrosis by Transient Elastography-CAP (FibroScan® With the CAP Probe)
Hepatic steatosis and fibrosis by transient elastography-CAP (FibroScan® with the CAP probe)
Measured: 48 weeks
Dietary Preferences (Using Food Preference Questionnaire for Adolescents and Adults)
Dietary preferences (using Food preference questionnaire for adolescents and adults)
Measured: 48 weeks
Quality of Life (EuroQoL Questionnaire)
Quality of Life (EuroQoL questionnaire)
Measured: 48 weeks
Sleep Quality (Pittsburgh Sleep Quality Index Questionnaire)
Sleep quality (Pittsburgh Sleep Quality Index questionnaire)
Measured: 48 weeks
Renal Safety by uPCR
Renal safety by uPCR
Measured: 48 weeks
Renal Safety by eGFR
Renal safety by eGFR
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start21 Nov 2023
- Primary completion21 Nov 2024
- Study completion21 Nov 2024
Why it stopped: The CI, sponsor and funder jointly made the decision to end the trial due to lack of recruitment, as well as due to delays it was felt value of the primary endpoint had lessened to a point where its scientific value was questioned.
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 HivStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289986
- Sponsor's protocol ID
- CRF006
- Acronym
- META-D
- Status last verified
- May 2026
- First submitted
- 26 Jan 2022
- Last updated
- 28 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will be provided reasonable access to statistical tables, figures, and relevant reports. Sponsor will also provide the investigators with the full summary of the study results. The investigator is encouraged to share the summary results with the study subjects, as appropriate. The procedures and timing for public disclosure of the results summary and for development of a manuscript for publication will be in accordance with sponsor policies.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch From Stable cART Containing ABA/3TC or TAF/FTC Plus Dolutegravir or Bictegravir to TDF/3TC/Doravirine in People Living With HIV: Impact on Lipids, Body Composition, Insulin Sensitivity, Neuroendocrine Function and Inflammation Markers
- ClinicalTrials.gov ID
- NCT05289986
- Acronym / sponsor ID
- META-D / CRF006
- Conditions
- Hiv
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The CI, sponsor and funder jointly made the decision to end the trial due to lack of recruitment, as well as due to delays it was felt value of the primary endpoint had lessened to a point where its scientific value was questioned.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Posted 28 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, randomised, two-arm switch study over 48 weeks in which virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period.
If patients withdraw or are withdrawn from the study treatment prematurely, an early termination visit (ETV) should occur within 30 days post withdrawal.
The hypothesis of the study is that a switch to Delstrigo, which is a combination of tenofovir disoproxil, lamivudine and doravirine (TDF/3TC/DOR) has a favourable impact on lipid metabolism, glucose, weight, body composition and hepatic steatosis.
Detailed description
Open-label, 2 arm, multi-centre, non-inferiority switch study.
Sample size: 60 participants
Participant population: HIV-1 infected patients on stable and suppressive triple cART.
IMP: Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine
- TDF/3TC/DOR)
Study setting: Patients will be identified through HIV clinic visits by their direct study medical care team and visits will be captured on a participant-screening log. A Trial Management Team will facilitate the project and liaise with participating sites in study set-up and progress.
Dose and Route of Administration:
Experimental arm (baseline visit switch group, N=30): One DOR/TDF/3TC tablet taken orally once daily for 48 weeks.
Control arm (deferred switch group, N=30): Participants will continue their current triple cART regimen for 24 weeks, and then switched to taking one TDF/3TC/DOR tablet orally once daily (24 -48 weeks).
Primary Objective To quantify the effect on lipid profile (change from baseline in total fasting cholesterol to Week 24) of switching from suppressive, stable cART containing ABA/3TC or TAF/FTC plus dolutegravir or bictegravir to Delstrigo (TDF/3TC/DOR) in HIV positive patients.
Secondary Objectives
To investigate the effect of switch on:
- Body composition changes when measured by Total Body DXA at week 24 and 48 and by waist circumference
- Change in insulin sensitivity from baseline to week 24 and 48 by HOMA-IR (glucose \& insulin levels)
- PBMC cholesterol and cholesteryl levels
- Adipocytokines by assessing adiponectin, leptin
- Pituitary hormones (TSH, LH, FSH, IGF-1, Testosterone)
- Estimated cardiovascular risk (QRISK3 and D:A:D equations)
- Hepatic steatosis and fibrosis by transient elastography-CAP (FibroScan® with the CAP probe)
- Dietary, Quality of Life (EuroQoL), and Sleep quality (Pittsburgh Sleep Quality Index) Questionnaires
- Renal safety by uPCR, eGFR Potential Exploratory Objectives Platelet aggregation \& endothelial markers, metabolomics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate switch arm | Experimental | Drug: DELSTRIGO 100Mg-300Mg-300Mg TabletExperimental arm (baseline visit switch group, N=30): One DOR/TDF/3TC tablet taken orally once daily for 48 weeks. Virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period. |
| delayed switch arm | Active comparator | Drug: DELSTRIGO 100Mg-300Mg-300Mg TabletControl arm (deferred switch group, N=30): Participants will continue their current triple cART regimen for 24 weeks, and then switched to taking one TDF/3TC/DOR tablet orally once daily (24 -48 weeks). Virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- HIV-1 infected, 18 years or older
- On stable \& suppressive triple cART containing ABA/3TC or TAF/FTC plus dolutegravir or bictegravir for at least 6 months
- No evidence of resistance to TDF, 3TC, or DOR
- No laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators
- Women who are of childbearing potential and sexually active need to use the hormonal contraceptive methods, associated with inhibition of ovulation, listed in the protocol:
Key exclusion criteria (14 listed)
- History of virological failure on an NNRTI in absence of a post-failure genotypic resistance test proving absence of resistance to DOR
- Concomitant medication contra-indicated with TDF, FTC or DOR
- Haemoglobin <9 g/dL
- Platelets <80,000/mm3
- Creatinine clearance <50 mL/min
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 |
|---|---|---|
| DELSTRIGO 100Mg-300Mg-300Mg TabletDelstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine - TDF/3TC/DOR) | Drug | delayed switch arm, immediate switch arm |
Primary outcome
To Quantify the Effect on Lipid Profile
Time frame: 24 weeks
To quantify the effect on lipid profile (change from baseline in total fasting cholesterol to Week 24) of switching from suppressive, stable cART containing ABA/3TC or TAF/FTC plus dolutegravir or bictegravir to Delstrigo (TDF/3TC/DOR) in HIV positive patients.
15 secondary outcomes
Percentage of Patients With Treatment-related Adverse Events by Week 48
Time frame: 48 weeks
Median Change in Body Fat Content (g) Measured by Total Body Dexa at Week 24 and 48
Time frame: 48 weeks
Body Composition Changes When Measured by Waist Circumference at Week 24 and 48
Time frame: 48 weeks
Change in Insulin Sensitivity From Baseline to Week 24 and 48 by HOMA-IR (Glucose & Insulin Levels)
Time frame: 48 weeks
PBMC Cholesterol and Cholesteryl Levels
Time frame: 48 weeks
Adipocytokines by Assessing Adiponectin, Leptin
Time frame: 48 weeks
Pituitary Hormones (TSH, LH, FSH, IGF-1, Testosterone)
Time frame: 48 weeks
Estimated Cardiovascular Risk (QRISK3 Equation)
Time frame: 48 weeks
Estimated Cardiovascular Risk (D:A:D Equation)
Time frame: 48 weeks
Hepatic Steatosis and Fibrosis by Transient Elastography-CAP (FibroScan® With the CAP Probe)
Time frame: 48 weeks
Dietary Preferences (Using Food Preference Questionnaire for Adolescents and Adults)
Time frame: 48 weeks
Quality of Life (EuroQoL Questionnaire)
Time frame: 48 weeks
Sleep Quality (Pittsburgh Sleep Quality Index Questionnaire)
Time frame: 48 weeks
Renal Safety by uPCR
Time frame: 48 weeks
Renal Safety by eGFR
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. The investigators will be provided reasonable access to statistical tables, figures, and relevant reports. Sponsor will also provide the investigators with the full summary of the study results. The investigator is encouraged to share the summary results with the study subjects, as appropriate. The procedures and timing for public disclosure of the results summary and for development of a manuscript for publication will be in accordance with sponsor policies.
Related trials for Hiv
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DELSTRIGO 100Mg-300Mg-300Mg Tablet in people with Hiv, run by Chelsea and Westminster NHS Foundation Trust at 2 sites in United Kingdom.
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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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. 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 28 May 2026). 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?
To Quantify the Effect on Lipid Profile (time frame: 24 weeks). 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 28 May 2026.