ObesityPhase 3TirBaSNCT07829198
Efficacy of Tirzepatide for Weight Management in Patients With Suboptimal Weight Loss After Bariatric Surgery: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
A Phase 3 study testing Tirzepatide in people with Obesity, run by Universidade do Porto at 3 sites in Portugal.
Trial summary
Many people who have bariatric (weight-loss) surgery do not lose as much weight as expected, or they regain weight over time. This study will test whether a medicine called tirzepatide can help these patients lose more weight and improve their overall health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesPortugal
- Study dates
- Jan 2027to Dec 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (male or female) aged ≥18 years.
- History of bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) performed ≥12 months before enrollment.
- Current BMI ≥30 kg/m².
- Evidence of suboptimal weight loss, defined as percentage total weight loss (%TWL) since surgery of less than 25% (defined as the percentage of weight loss comparing current body weight with body weight before surgery).
- Absence of recent weight loss (defined as <5% reduction in body weight over the 6 months prior to screening); participants may be weight stable (<5% variation in body weight over the 6 months prior to screening) or have experienced weight gain.
- In the investigator's opinion, well-motivated, capable, and willing to comply with study procedures.
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- For male participants: male participants with partners of childbearing potential should be willing to use reliable contraceptive methods throughout the study and for 5 half-lives of study drug plus 90 days, corresponding to 4 months after the last injection.
- For female participants:
- Female participants not of childbearing potential may participate and include those who are: i. infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation), congenital anomaly such as Mullerian agenesis ii. postmenopausal, defined as either:
- a woman at least 40 years of age with an intact uterus, not on hormone therapy, who has cessation of menses for at least 1 year without an alternative medical cause, AND a follicle-stimulating hormone ≥40mIU/mL; women in this category must test negative in pregnancy test prior to study entry
- a woman 55 or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea
- a woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy b. Female participants of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must:
- test negative for pregnancy at Visit 1 based on a serum pregnancy test
- if sexually active, agree to use 2 forms of effective contraception, where at least 1 form is highly effective, for the duration of the trial and for 30 days thereafter
- not be breastfeeding
- Provision of written informed consent prior to any study-specific procedures.
Who cannot join
- Use of a GLP-1 receptor agonist (GLP-1 RA) or any other GLP-1-based therapy at present or within the past 6 months.
- Prescription of a GLP-1 RA or other GLP-1-based therapy within the past 12 months that could not be initiated or maintained due to drug supply shortages.
- Have a planned surgical treatment, endoscopic and/or device-based therapy for obesity during the period of the study.
- History of type 1 diabetes or uncontrolled type 2 diabetes (HbA1c >10%).
- Type 2 diabetes currently treated with insulin or sulfonylureas.
- Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility.
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- Have had a history of chronic or acute pancreatitis.
- Have NYHA Functional Classification III or IV heart failure.
- Have thyroid-stimulating hormone (TSH) outside of the reference range at screening visit.
- Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome).
- Have a history of significant active or unstable Major Depressive Disorder or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years.
- Have any lifetime history of a suicide attempt.
- Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia (MEN) Syndrome type 2.
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
- Participation in another clinical study with an investigational product during the last month.
- Unwilling or unable to sign the informed consent form.
- History of active malignancy within the past 5 years (except adequately treated non-melanoma skin cancer or in situ carcinoma of the cervix).
- Known hypersensitivity or contraindication to tirzepatide or any of its excipients.
- Have severe hepatic impairment (Child-Pugh class C).
- Have severe renal impairment (eGFR <30 mL/min/1.73 m² using CKD-EPI formula).
- Are receiving or have received within 3 months prior to screening chronic (>2 weeks or 14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) or have evidence of a significant, active autoimmune abnormality (for example, lupus or rheumatoid arthritis) that has required (within the last 3 months) or is likely to require, in the opinion of the investigator, concurrent treatment with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular or inhaled preparations) in the next 12 months.
- For female patients, pregnancy, breastfeeding, or planning pregnancy during the study period.
- Any condition which, in the investigator's opinion, may jeopardize the subject's safety or compliance with the protocol (e.g., severe psychiatric illness, alcohol or substance abuse).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal3 sites
Unidade Local de Saúde de Santo António
Porto
Teresa Pereira, +351 961543537, teresa.rocha.pereira@gmail.com
Unidade Local de Saúde de São João
Porto
Paula Freitas, +351 966869160, paula_freitas@sapo.pt
Unidade Local de Saúde de Entre Douro e Vouga
Santa Maria da Feira
Mariana Monteiro, +351 919875148, mpmonteiro.icbas@gmail.com
About this study
Many people who have bariatric (weight-loss) surgery do not lose as much weight as expected, or they regain weight over time. This study will test whether a medicine called tirzepatide can help these patients lose more weight and improve their overall health.
Participants who had bariatric surgery at least one year ago and still have obesity with insufficient weight loss will be randomly assigned, like a coin flip, to receive either tirzepatide or a placebo (an inactive injection that looks the same). Neither participants nor study staff will know who is receiving which treatment.
Read more
Participants will inject the study medicine or placebo once a week for 52 weeks, starting at a low dose that is gradually increased. During the study, researchers will measure body weight, waist size, blood pressure, and blood tests related to metabolism and inflammation. Participants will also answer questionnaires about their quality of life.
The main goal is to find out whether tirzepatide leads to greater weight loss than placebo after one year of treatment.
Read the detailed description
TirBaS is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating the efficacy of tirzepatide, a dual GIP/GLP-1 receptor agonist, for weight management in adults with a history of bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) performed at least 12 months prior to enrollment, who present with suboptimal weight loss or weight regain.
A total of 70 participants will be randomized in a 1:1 ratio to receive either tirzepatide or matching placebo, administered once weekly by subcutaneous injection. Randomization will be stratified by type of bariatric surgery, baseline BMI category, and time since surgery. Tirzepatide will be up-titrated in 2.5 mg increments every 4 weeks, up to a maximum of 15 mg or the maximum tolerated dose, with weekly dosing continuing through week 52 of the 52-week treatment period.
The primary objective is to assess the effect of tirzepatide versus placebo on the percentage change in body weight from baseline to week 52. Secondary objectives include evaluating changes in cardiometabolic parameters (body weight, BMI, waist circumference, blood pressure, HbA1c, fasting glucose, lipid profile, kidney function, liver profile), inflammatory status (hs-CRP), the proportion of participants achieving clinically meaningful weight loss thresholds (≥5%, ≥10%, ≥15%, ≥20%), and quality of life, assessed using the IWQOL-Lite-CT, EQ-5D-5L, SF-36, and a study-specific Patient Global Impression of Status (PGIS) item.
Participants will attend six study visits over 52 weeks (Weeks 0, 8, 16, 24, 36, and 52), including anthropometric measurements, vital signs, laboratory safety assessments, and adverse event monitoring. Optional biobanking of blood and urine samples will be offered at Visits 1, 4, and 6 for future research, subject to separate informed consent.
The primary analysis will follow the intention-to-treat principle, using an analysis of covariance (ANCOVA) model adjusted for baseline weight and stratification factors. Secondary continuous outcomes will be analyzed using mixed-model repeated measures (MMRM), and categorical outcomes using logistic regression. No interim analysis is planned.
- Conditions
- Obesity
- Being tested
- Tirzepatide, Placebo
- Keywords
- Tirzepatide, GLP-1 receptor agonist, Bariatric surgery, Weight regain
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Dual GIP/GLP-1 receptor agonist supplied as a prefilled syringe (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg) for subcutaneous injection, manufactured by Eli Lilly and Company. Self-administered once weekly by the participant in the abdomen, thigh, or upper arm, with rotating injection sites. Dose up-titrated every 4 weeks in 2.5 mg increments, up to a maximum of 15 mg or the maximum tolerated dose, for a total treatment duration of 52 weeks.
PlaceboDrug
Matching placebo, supplied as a prefilled syringe identical in appearance to the tirzepatide syringe, manufactured by Eli Lilly and Company. Self-administered once weekly by subcutaneous injection, following the same up-titration schedule, injection sites, and visit schedule as the tirzepatide arm, for a total of 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Participants will receive tirzepatide once weekly by subcutaneous injection, self-administered at home. Treatment will start at 2.5 mg once weekly, with up-titration in 2.5 mg increments every 4 weeks (5 mg, 7.5 mg, 10 mg, 12.5 mg, up to 15 mg), according to tolerability, up to the maximum tolerated dose or 15 mg once weekly. Treatment will continue for a total of 52 weeks. Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Participants will receive matching placebo (identical prefilled syringe) once weekly by subcutaneous injection, self-administered at home, following the same up-titration schedule and visit schedule as the tirzepatide arm, for a total of 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Body Weight from Baseline to Week 52
To assess the effect of tirzepatide versus placebo on the percentage change in body weight relative to baseline at week 52
Measured: Baseline (Week 0) to Week 52
Secondary outcomes (15)
Change in Body Weight
Change in body weight (kg) from baseline.
Measured: From baseline to Weeks 8, 16, 24, 36, and 52
Change in Body Mass Index (BMI)
Change in BMI, calculated as body weight in kilograms divided by the square of height in meters
Measured: From baseline to Weeks 8, 16, 24, 36, and 52
Change in Waist Circumference
Change in waist circumference (cm)
Measured: From baseline to Weeks 8, 16, 24, 36, and 52
Change in Blood Pressure
Change in systolic and diastolic blood pressure (mmHg), measured in triplicate after rest.
Measured: From baseline to Weeks 8, 16, 24, 36, and 52
Change in Glycated Hemoglobin (HbA1c)
Change in HbA1c (%, mmol/mol), measured at the local laboratory
Measured: From baseline to Week 52
Change in Fasting Glucose
Change in fasting glucose, measured at the local laboratory.
Measured: From baseline to Week 52
Change in Lipid Profile
Change in lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides), measured at the local laboratory.
Measured: From baseline to Week 52
Change in Kidney Function
Change in kidney function, including estimated glomerular filtration rate (eGFR, CKD-EPI formula) and creatinine.
Measured: From baseline to Week 52
Change in Liver Profile
Change in liver profile (ALT, AST, GGT, alkaline phosphatase, total bilirubin, direct bilirubin)
Measured: From baseline to Week 52
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Change in high-sensitivity C-reactive protein (hs-CRP), an assessment of inflammatory status.
Measured: From baseline to Week 52
Proportion of Participants Achieving Clinically Meaningful Weight Loss
Proportion of participants achieving weight loss thresholds of ≥5%, ≥10%, ≥15%, and ≥20% at week 52, derived from body weight measurements.
Measured: At Week 52
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score
Change in IWQOL-Lite-CT, a 20-item obesity-specific patient-reported outcome instrument assessing physical and psychosocial domains of health-related quality of life.
Measured: From baseline to Week 52
Change in EQ-5D-5L Score
Change in EQ-5D-5L, a standardized instrument assessing 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), including index value and EQ Visual Analog Scale.
Measured: From baseline to Week 52
Change in Short Form 36 version 2 (SF-36v2) Score
Change in SF-36v2 (acute, 1-week recall version) across 8 domains, aggregated into Physical-Component and Mental-Component summary scores.
Measured: From baseline to Week 52
Change in Patient Global Impression of Status (PGIS)
Change in PGIS, a patient-rated assessment of current health limitation on a 5-point scale.
Measured: From baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Mariana Monteiro, Principal investigator, Unidade Local de Saúde de Entre Douro e VougaPaula Freitas, Principal investigator, Unidade Local de Saúde de São JoãoTeresa Pereira, Principal investigator, Unidade Local de Saúde de Santo António
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829198
- Sponsor's protocol ID
- TirBaS
- Other IDs
- 2026-527275-29-00
- Acronym
- TirBaS
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tirzepatide for Weight Management in Patients With Suboptimal Weight Loss After Bariatric Surgery: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07829198
- Acronym / sponsor ID
- TirBaS / TirBaS
- Conditions
- Obesity
- Keywords
- Tirzepatide, GLP-1 receptor agonist, Bariatric surgery, Weight regain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Sep 2026 (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.
Many people who have bariatric (weight-loss) surgery do not lose as much weight as expected, or they regain weight over time. This study will test whether a medicine called tirzepatide can help these patients lose more weight and improve their overall health.
Participants who had bariatric surgery at least one year ago and still have obesity with insufficient weight loss will be randomly assigned, like a coin flip, to receive either tirzepatide or a placebo (an inactive injection that looks the same). Neither participants nor study staff will know who is receiving which treatment.
Participants will inject the study medicine or placebo once a week for 52 weeks, starting at a low dose that is gradually increased. During the study, researchers will measure body weight, waist size, blood pressure, and blood tests related to metabolism and inflammation. Participants will also answer questionnaires about their quality of life.
The main goal is to find out whether tirzepatide leads to greater weight loss than placebo after one year of treatment.
Detailed description
TirBaS is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating the efficacy of tirzepatide, a dual GIP/GLP-1 receptor agonist, for weight management in adults with a history of bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) performed at least 12 months prior to enrollment, who present with suboptimal weight loss or weight regain.
A total of 70 participants will be randomized in a 1:1 ratio to receive either tirzepatide or matching placebo, administered once weekly by subcutaneous injection. Randomization will be stratified by type of bariatric surgery, baseline BMI category, and time since surgery. Tirzepatide will be up-titrated in 2.5 mg increments every 4 weeks, up to a maximum of 15 mg or the maximum tolerated dose, with weekly dosing continuing through week 52 of the 52-week treatment period.
The primary objective is to assess the effect of tirzepatide versus placebo on the percentage change in body weight from baseline to week 52. Secondary objectives include evaluating changes in cardiometabolic parameters (body weight, BMI, waist circumference, blood pressure, HbA1c, fasting glucose, lipid profile, kidney function, liver profile), inflammatory status (hs-CRP), the proportion of participants achieving clinically meaningful weight loss thresholds (≥5%, ≥10%, ≥15%, ≥20%), and quality of life, assessed using the IWQOL-Lite-CT, EQ-5D-5L, SF-36, and a study-specific Patient Global Impression of Status (PGIS) item.
Participants will attend six study visits over 52 weeks (Weeks 0, 8, 16, 24, 36, and 52), including anthropometric measurements, vital signs, laboratory safety assessments, and adverse event monitoring. Optional biobanking of blood and urine samples will be offered at Visits 1, 4, and 6 for future research, subject to separate informed consent.
The primary analysis will follow the intention-to-treat principle, using an analysis of covariance (ANCOVA) model adjusted for baseline weight and stratification factors. Secondary continuous outcomes will be analyzed using mixed-model repeated measures (MMRM), and categorical outcomes using logistic regression. No interim analysis is planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideParticipants will receive tirzepatide once weekly by subcutaneous injection, self-administered at home. Treatment will start at 2.5 mg once weekly, with up-titration in 2.5 mg increments every 4 weeks (5 mg, 7.5 mg, 10 mg, 12.5 mg, up to 15 mg), according to tolerability, up to the maximum tolerated dose or 15 mg once weekly. Treatment will continue for a total of 52 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo (identical prefilled syringe) once weekly by subcutaneous injection, self-administered at home, following the same up-titration schedule and visit schedule as the tirzepatide arm, for a total of 52 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adults (male or female) aged ≥18 years.
- History of bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) performed ≥12 months before enrollment.
- Current BMI ≥30 kg/m².
- Evidence of suboptimal weight loss, defined as percentage total weight loss (%TWL) since surgery of less than 25% (defined as the percentage of weight loss comparing current body weight with body weight before surgery).
- Absence of recent weight loss (defined as <5% reduction in body weight over the 6 months prior to screening); participants may be weight stable (<5% variation in body weight over the 6 months prior to screening) or have experienced weight gain.
Key exclusion criteria (23 listed)
- Use of a GLP-1 receptor agonist (GLP-1 RA) or any other GLP-1-based therapy at present or within the past 6 months.
- Prescription of a GLP-1 RA or other GLP-1-based therapy within the past 12 months that could not be initiated or maintained due to drug supply shortages.
- Have a planned surgical treatment, endoscopic and/or device-based therapy for obesity during the period of the study.
- History of type 1 diabetes or uncontrolled type 2 diabetes (HbA1c >10%).
- Type 2 diabetes currently treated with insulin or sulfonylureas.
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 |
|---|---|---|
| TirzepatideDual GIP/GLP-1 receptor agonist supplied as a prefilled syringe (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg) for subcutaneous injection, manufactured by Eli Lilly and Company. Self-administered once weekly by the participant in the abdomen, thigh, or upper arm, with rotating injection sites. Dose up-titrated every 4 weeks in 2.5 mg increments, up to a maximum of 15 mg or the maximum tolerated dose, for a total treatment duration of 52 weeks. | Drug | Tirzepatide |
| PlaceboMatching placebo, supplied as a prefilled syringe identical in appearance to the tirzepatide syringe, manufactured by Eli Lilly and Company. Self-administered once weekly by subcutaneous injection, following the same up-titration schedule, injection sites, and visit schedule as the tirzepatide arm, for a total of 52 weeks | Drug | Placebo |
Primary outcome
Percentage Change in Body Weight from Baseline to Week 52
Time frame: Baseline (Week 0) to Week 52
To assess the effect of tirzepatide versus placebo on the percentage change in body weight relative to baseline at week 52
15 secondary outcomes
Change in Body Weight
Time frame: From baseline to Weeks 8, 16, 24, 36, and 52
Change in Body Mass Index (BMI)
Time frame: From baseline to Weeks 8, 16, 24, 36, and 52
Change in Waist Circumference
Time frame: From baseline to Weeks 8, 16, 24, 36, and 52
Change in Blood Pressure
Time frame: From baseline to Weeks 8, 16, 24, 36, and 52
Change in Glycated Hemoglobin (HbA1c)
Time frame: From baseline to Week 52
Change in Fasting Glucose
Time frame: From baseline to Week 52
Change in Lipid Profile
Time frame: From baseline to Week 52
Change in Kidney Function
Time frame: From baseline to Week 52
Change in Liver Profile
Time frame: From baseline to Week 52
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: From baseline to Week 52
Proportion of Participants Achieving Clinically Meaningful Weight Loss
Time frame: At Week 52
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score
Time frame: From baseline to Week 52
Change in EQ-5D-5L Score
Time frame: From baseline to Week 52
Change in Short Form 36 version 2 (SF-36v2) Score
Time frame: From baseline to Week 52
Change in Patient Global Impression of Status (PGIS)
Time frame: From baseline to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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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.
Mariana Monteiro principal investigator
Unidade Local de Saúde de Entre Douro e Vouga
Paula Freitas principal investigator
Unidade Local de Saúde de São João
Teresa Pereira principal investigator
Unidade Local de Saúde de Santo António
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirzepatide in people with Obesity, run by Universidade do Porto at 3 sites in Portugal.
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 16 inclusion and 23 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: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Janete Santos, PhD (+351 220 426 569, investigaclinica@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Body Weight from Baseline to Week 52 (time frame: Baseline (Week 0) to Week 52). 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 18 Sep 2026.