ObesityPhase 3NCT07332273
Levothyroxine as Adjuvant to a Hypocaloric Diet for the Treatment of Obesity.
A Phase 3 study testing Levothyroxine in people with Obesity, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 5 sites in Spain.
Trial summary
Obesity is a chronic disease with high relapse rates after initial weight loss. Thyroid hormones modulate energy expenditure, body composition, and thermogenesis; higher TSH within the reference range and subclinical hypothyroidism have been associated with adverse metabolic profiles and weight gain. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Levothyroxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 5 sitesSpain
- Study dates
- 5 Nov 2025to May 2027
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults 25-60 years of age.
- Obesity grade I-II: BMI 30.0-39.9 kg/m².
- Either subclinical hypothyroidism (TSH 5-10 mIU/L with normal peripheral hormones) or euthyroid with TSH in the highest tertile of the population reference range (no known thyroid disease).
- Able and willing to provide written informed consent.
- Women of childbearing potential: not pregnant or breastfeeding and using a highly effective contraception method (failure rate <1%) per CTCG guidance (e.g., hormonal methods, IUD/IUS, sterilization, or dual barrier with spermicide).
Who cannot join
- Diabetes mellitus (HbA1c ≥6.5%, fasting glucose ≥126 mg/dL, or 2-h OGTT ≥200 mg/dL).
- Any prior thyroid disease (hyperthyroidism, overt hypothyroidism) or prior LT4 treatment.
- Current or recent (≤3 months) use of levothyroxine, hypoglycaemic agents, antibiotics, or regular probiotics/prebiotics.
- Active cancer or cancer within the last 5 years (except basal-cell carcinoma).
- Chronic liver disease with total bilirubin ≥2.0 mg/dL or AST >3× ULN.
- Established cardiovascular disease (e.g., stroke, ischemic heart disease, peripheral artery disease).
Show all 16Show fewer
- Atrial fibrillation or any arrhythmia history.
- Uncontrolled hypertension (>160/100 mmHg) despite therapy (assessed by ABPM at screening).
- Any heart failure; resting HR >85 bpm; eGFR <60 mL/min.
- Known HIV, HBV, or HCV infection.
- Acute inflammatory disease or inflammatory bowel disease.
- Serious underlying disease that, in the investigator's judgment, could affect participation.
- Drug/alcohol abuse, life expectancy <12 months, inability to follow the recommended diet or attend visits.
- Positive pregnancy test, pregnant, expecting pregnancy, or breastfeeding.
- Hypersensitivity to any component of the investigational product.
- Inability or unwillingness to provide informed consent.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Not yet recruiting
Hospital Puerta del Mar
Cadiz
- Not yet recruiting
Hospital Reina Sofía
Córdoba
- Not yet recruiting
Hospital Universitario de Jaén
Jaén
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga
Isabel María Cornejo, 620750452, isabelmaria.cornejo@gmail.com
- Not yet recruiting
Hospital Clínico Universitario de Valladolid
Valladolid
About this study
Official title: Effect of Levothyroxine as Adjuvant Therapy to a Hypocaloric Diet in the Treatment of Obesity: a Randomized Placebo-controlled Trial.
Obesity is a chronic disease with high relapse rates after initial weight loss. Thyroid hormones modulate energy expenditure, body composition, and thermogenesis; higher TSH within the reference range and subclinical hypothyroidism have been associated with adverse metabolic profiles and weight gain. These signals suggest the thyroid axis could influence weight-loss response and subsequent regain. Levothyroxine (LT4) is widely used for hypothyroidism; evaluating its adjuvant role in obesity management is clinically relevant.
This is a phase III, randomized, double-blind, placebo-controlled, multicentre clinical trial conducted in five Spanish hospitals. A total of 286 adults (25-60 years) with grade I-II obesity will be enrolled if they have subclinical hypothyroidism (TSH 5-10 mIU/L with normal peripheral hormones) or are euthyroid with TSH in the highest tertile of the reference range. Participants are randomized 1:1, stratified by age, sex, and BMI.
Read more
Intervention: LT4 88 µg once daily or matching placebo for 9 months. During months 0-3, all participants receive a structured hypocaloric Mediterranean diet (≈600 kcal/day deficit; macronutrients 45% carbohydrates, 35% fats, 20% proteins) plus standardized physical-activity advice. From months 3-9, lifestyle support continues with a normocaloric Mediterranean diet. Physical-activity guidance targets ≥150 min/week of moderate-to-vigorous activity (spread over ≥3 days) and 2-3 resistance sessions/week.
Primary endpoint (3 months): change in body weight (kg and %) and body composition (BMI, waist/hip circumferences, fat mass, fat-free mass, total body water by bioimpedance) comparing LT4 versus placebo under the same lifestyle program. The study is powered for n=286.
Key secondary endpoints (up to 9 months): prevention of weight regain; changes in obesity stage; cardiometabolic markers (lipids, glucose/HbA1c, HOMA-IR, adipokines, inflammation, blood-pressure patterns); resting energy expenditure by indirect calorimetry; objectively measured physical activity by accelerometry; cardiac parameters (ECG) and safety; quality of life (EuroQol-5D). Mechanistic substudies assess adipose-tissue metabolic activity (gene/protein expression, browning markers, mitochondrial DNA) and explore gut microbiota, epigenetic signatures, nitrogen balance, and sex-specific differences in response.
Assessments are performed at baseline and follow-up visits through 9 months and include anthropometry, bioimpedance, laboratory panels, indirect calorimetry, ambulatory blood-pressure monitoring, ECG, diet/physical-activity questionnaires, and biobanking of blood, urine, and stool; an adipose-tissue biopsy is obtained in a subsample.
The trial uses intention-to-treat analyses with mixed linear models and is designed with 90% power to detect a clinically meaningful between-group difference in 3-month weight loss; total sample size is 286 (143 per arm). Overall study duration is 21 months (12 months of recruitment plus 9 months of treatment/follow-up); each participant remains in the study for 9 months.
In summary, this trial tests whether adding LT4 88 µg/day to a structured Mediterranean-diet and exercise program enhances early weight loss and helps prevent regain versus placebo in adults with obesity and high-normal TSH or subclinical hypothyroidism, while characterizing metabolic mechanisms and biomarkers of response.
- Conditions
- Obesity
- Being tested
- Levothyroxine, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
Film-coated oral tablets containing levothyroxine 88 mcg, taken once daily for 9 months. All participants receive a structured lifestyle program: months 0-3 hypocaloric Mediterranean diet (~600 kcal/day deficit) with physical-activity advice; months 3-9 normocaloric Mediterranean diet with continued advice. The IMP is purchased from authorized manufacturers, then reconditioned and relabeled per GMP and supplied blinded for the full study period. Dispensing follows the randomization code; emergency unblinding only via the hospital pharmacy. Store per label (do not store above 25 °C); adherence assessed by pill count and self-report.
PlaceboDrug
(white, plain, circular), oral once daily for 9 months, no active ingredient. Administered alongside the same lifestyle program as the active arm (months 0-3 hypocaloric Mediterranean diet; months 3-9 normocaloric Mediterranean diet). Placebo is reconditioned and relabeled per GMP to be indistinguishable from levothyroxine; supply is blinded and dispensed per randomization code. Emergency unblinding is performed only by the pharmacy service when medically necessary.
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine 88mcg | Experimental | Not described Receives: Drug: Levothyroxine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight (kg) from baseline to Month 3
Measured: Baseline to Month 3 (12 weeks ±2)
Change in fat mass (kg) by bioimpedance from baseline to Month 3
Measured: Baseline to Month 3 (12 weeks ±2)
Secondary outcomes (21)
Weight-regain (kg) from Month 3 to Month 9
Measured: Month 3 to Month 9 (36 weeks ±2)
Change in BMI (kg/m²) from baseline to Month 9
Measured: Baseline to Month 9
Change in waist circumference (cm) from baseline to Month 9
Measured: Baseline to Month 9
Change in fasting LDL-cholesterol (mg/dL) from baseline to Month 9
Measured: Baseline to Month 9
Change in glycaemic control (HbA1c, %) from baseline to Month 9
Measured: Baseline to Month 9
Change in insulin resistance (HOMA-IR) from baseline to Month 9
Measured: Baseline to Month 9
Change in resting energy expenditure (kcal/day) by indirect calorimetry from baseline to Month 9
Measured: Baseline to Month 9
Change in physical activity level measured by accelerometry
Physical activity will be quantified by accelerometry using the ActiGraph WGT3X-BT device, worn for 7 consecutive days before and after the intervention periods, as specified in the protocol.
Measured: Baseline to Month 9
Change in blood pressure parameters assessed by ambulatory blood pressure monitoring (ABPM) from baseline to Month 9
Ambulatory blood pressure monitoring (24-hour ABPM) will be performed to register possible blood pressure adverse events, as specified in the protocol.
Measured: Baseline to Month 9
Change in heart rate measured by electrocardiogram (ECG) from baseline to Month 9
Cardiac evaluation will be performed by electrocardiogram (ECG). Minimum, maximum and average heart rates will be assessed as specified in the protocol.
Measured: Baseline to Month 9
Change in number of ventricular extrasystoles measured by electrocardiogram (ECG) from baseline to Month 9
The number of ventricular extrasystoles will be assessed by electrocardiogram (ECG) during cardiac evaluation, according to the protocol.
Measured: Baseline to Month 9
Change in QT interval measured by electrocardiogram (ECG) from baseline to Month 9
QT interval will be evaluated by electrocardiogram (ECG) as part of the cardiac assessment described in the protocol.
Measured: Baseline to Month 9
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: From first dose to Month 9
Change in quality of life measured by EuroQol-5D index from baseline to Month 9
Measured: Baseline to Month 9
Change in quality of life measured by EuroQol-5D visual analogue scale (VAS) from baseline to Month 9
Measured: Baseline to Month 9
Change in gene expression related to metabolic activity in adipose tissue (subsample)
Gene expression changes in adipose tissue samples related to lipogenic and lipolytic capacity, adipokines, thyroid receptor and browning biomarkers will be analyzed, as described in the protocol.
Measured: Baseline to Month 3
Change in protein abundance related to metabolic activity in adipose tissue (subsample)
Protein abundance changes in adipose tissue samples related to metabolic activity will be evaluated according to the protocol.
Measured: Baseline to Month 3
Change in mitochondrial DNA in adipose tissue (subsample)
Mitochondrial DNA in adipose tissue samples will be analyzed as part of the metabolic activity assessment described in the protocol.
Measured: Baseline to Month 3
Change in gut microbiota diversity determined by 16S rRNA gene sequencing from baseline to Month 9
Measured: Baseline to Month 9
Change in relative abundance of gut microbiota taxa determined by 16S rRNA gene sequencing from baseline to Month 9
Measured: Baseline to Month 9
Change in nitrogen balance (g/day) from baseline to Month 9
Measured: Baseline to Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start5 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332273
- Sponsor's protocol ID
- LEVOBESITY
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the published results and the data dictionary will be made available to the scientific community via institutional repositories, following FAIR principles and Spanish/EU data protection law (LOPD 3/2018; GDPR). Participants are informed about data use and re-use; personal identifiers are removed and study data are stored on encrypted, password-protected servers. Access will be provided after primary results publication, subject to a reasonable request and a data use agreement consistent with GDPR; supporting documents (protocol, SAP, blank CRFs) and code will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Levothyroxine as Adjuvant Therapy to a Hypocaloric Diet in the Treatment of Obesity: a Randomized Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT07332273
- Acronym / sponsor ID
- LEVOBESITY
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 Jan 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.
Obesity is a chronic disease with high relapse rates after initial weight loss. Thyroid hormones modulate energy expenditure, body composition, and thermogenesis; higher TSH within the reference range and subclinical hypothyroidism have been associated with adverse metabolic profiles and weight gain. These signals suggest the thyroid axis could influence weight-loss response and subsequent regain. Levothyroxine (LT4) is widely used for hypothyroidism; evaluating its adjuvant role in obesity management is clinically relevant.
This is a phase III, randomized, double-blind, placebo-controlled, multicentre clinical trial conducted in five Spanish hospitals. A total of 286 adults (25-60 years) with grade I-II obesity will be enrolled if they have subclinical hypothyroidism (TSH 5-10 mIU/L with normal peripheral hormones) or are euthyroid with TSH in the highest tertile of the reference range. Participants are randomized 1:1, stratified by age, sex, and BMI.
Intervention: LT4 88 µg once daily or matching placebo for 9 months. During months 0-3, all participants receive a structured hypocaloric Mediterranean diet (≈600 kcal/day deficit; macronutrients 45% carbohydrates, 35% fats, 20% proteins) plus standardized physical-activity advice. From months 3-9, lifestyle support continues with a normocaloric Mediterranean diet. Physical-activity guidance targets ≥150 min/week of moderate-to-vigorous activity (spread over ≥3 days) and 2-3 resistance sessions/week.
Primary endpoint (3 months): change in body weight (kg and %) and body composition (BMI, waist/hip circumferences, fat mass, fat-free mass, total body water by bioimpedance) comparing LT4 versus placebo under the same lifestyle program. The study is powered for n=286.
Key secondary endpoints (up to 9 months): prevention of weight regain; changes in obesity stage; cardiometabolic markers (lipids, glucose/HbA1c, HOMA-IR, adipokines, inflammation, blood-pressure patterns); resting energy expenditure by indirect calorimetry; objectively measured physical activity by accelerometry; cardiac parameters (ECG) and safety; quality of life (EuroQol-5D). Mechanistic substudies assess adipose-tissue metabolic activity (gene/protein expression, browning markers, mitochondrial DNA) and explore gut microbiota, epigenetic signatures, nitrogen balance, and sex-specific differences in response.
Assessments are performed at baseline and follow-up visits through 9 months and include anthropometry, bioimpedance, laboratory panels, indirect calorimetry, ambulatory blood-pressure monitoring, ECG, diet/physical-activity questionnaires, and biobanking of blood, urine, and stool; an adipose-tissue biopsy is obtained in a subsample.
The trial uses intention-to-treat analyses with mixed linear models and is designed with 90% power to detect a clinically meaningful between-group difference in 3-month weight loss; total sample size is 286 (143 per arm). Overall study duration is 21 months (12 months of recruitment plus 9 months of treatment/follow-up); each participant remains in the study for 9 months.
In summary, this trial tests whether adding LT4 88 µg/day to a structured Mediterranean-diet and exercise program enhances early weight loss and helps prevent regain versus placebo in adults with obesity and high-normal TSH or subclinical hypothyroidism, while characterizing metabolic mechanisms and biomarkers of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine 88mcg | Experimental | Drug: Levothyroxine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults 25-60 years of age.
- Obesity grade I-II: BMI 30.0-39.9 kg/m².
- Either subclinical hypothyroidism (TSH 5-10 mIU/L with normal peripheral hormones) or euthyroid with TSH in the highest tertile of the population reference range (no known thyroid disease).
- Able and willing to provide written informed consent.
- Women of childbearing potential: not pregnant or breastfeeding and using a highly effective contraception method (failure rate <1%) per CTCG guidance (e.g., hormonal methods, IUD/IUS, sterilization, or dual barrier with spermicide).
Key exclusion criteria (16 listed)
- Diabetes mellitus (HbA1c ≥6.5%, fasting glucose ≥126 mg/dL, or 2-h OGTT ≥200 mg/dL).
- Any prior thyroid disease (hyperthyroidism, overt hypothyroidism) or prior LT4 treatment.
- Current or recent (≤3 months) use of levothyroxine, hypoglycaemic agents, antibiotics, or regular probiotics/prebiotics.
- Active cancer or cancer within the last 5 years (except basal-cell carcinoma).
- Chronic liver disease with total bilirubin ≥2.0 mg/dL or AST >3× ULN.
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 |
|---|---|---|
| LevothyroxineFilm-coated oral tablets containing levothyroxine 88 mcg, taken once daily for 9 months. All participants receive a structured lifestyle program: months 0-3 hypocaloric Mediterranean diet (~600 kcal/day deficit) with physical-activity advice; months 3-9 normocaloric Mediterranean diet with continued advice. The IMP is purchased from authorized manufacturers, then reconditioned and relabeled per GMP and supplied blinded for the full study period. Dispensing follows the randomization code; emergency unblinding only via the hospital pharmacy. Store per label (do not store above 25 °C); adherence assessed by pill count and self-report. | Drug | Levothyroxine 88mcg |
| Placebo(white, plain, circular), oral once daily for 9 months, no active ingredient. Administered alongside the same lifestyle program as the active arm (months 0-3 hypocaloric Mediterranean diet; months 3-9 normocaloric Mediterranean diet). Placebo is reconditioned and relabeled per GMP to be indistinguishable from levothyroxine; supply is blinded and dispensed per randomization code. Emergency unblinding is performed only by the pharmacy service when medically necessary. | Drug | Placebo |
Primary outcome
Change in body weight (kg) from baseline to Month 3
Time frame: Baseline to Month 3 (12 weeks ±2)
Change in fat mass (kg) by bioimpedance from baseline to Month 3
Time frame: Baseline to Month 3 (12 weeks ±2)
21 secondary outcomes
Weight-regain (kg) from Month 3 to Month 9
Time frame: Month 3 to Month 9 (36 weeks ±2)
Change in BMI (kg/m²) from baseline to Month 9
Time frame: Baseline to Month 9
Change in waist circumference (cm) from baseline to Month 9
Time frame: Baseline to Month 9
Change in fasting LDL-cholesterol (mg/dL) from baseline to Month 9
Time frame: Baseline to Month 9
Change in glycaemic control (HbA1c, %) from baseline to Month 9
Time frame: Baseline to Month 9
Change in insulin resistance (HOMA-IR) from baseline to Month 9
Time frame: Baseline to Month 9
Change in resting energy expenditure (kcal/day) by indirect calorimetry from baseline to Month 9
Time frame: Baseline to Month 9
Change in physical activity level measured by accelerometry
Time frame: Baseline to Month 9
Change in blood pressure parameters assessed by ambulatory blood pressure monitoring (ABPM) from baseline to Month 9
Time frame: Baseline to Month 9
Change in heart rate measured by electrocardiogram (ECG) from baseline to Month 9
Time frame: Baseline to Month 9
Change in number of ventricular extrasystoles measured by electrocardiogram (ECG) from baseline to Month 9
Time frame: Baseline to Month 9
Change in QT interval measured by electrocardiogram (ECG) from baseline to Month 9
Time frame: Baseline to Month 9
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From first dose to Month 9
Change in quality of life measured by EuroQol-5D index from baseline to Month 9
Time frame: Baseline to Month 9
Change in quality of life measured by EuroQol-5D visual analogue scale (VAS) from baseline to Month 9
Time frame: Baseline to Month 9
Change in gene expression related to metabolic activity in adipose tissue (subsample)
Time frame: Baseline to Month 3
Change in protein abundance related to metabolic activity in adipose tissue (subsample)
Time frame: Baseline to Month 3
Change in mitochondrial DNA in adipose tissue (subsample)
Time frame: Baseline to Month 3
Change in gut microbiota diversity determined by 16S rRNA gene sequencing from baseline to Month 9
Time frame: Baseline to Month 9
Change in relative abundance of gut microbiota taxa determined by 16S rRNA gene sequencing from baseline to Month 9
Time frame: Baseline to Month 9
Change in nitrogen balance (g/day) from baseline to Month 9
Time frame: Baseline to Month 9
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 12 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the published results and the data dictionary will be made available to the scientific community via institutional repositories, following FAIR principles and Spanish/EU data protection law (LOPD 3/2018; GDPR). Participants are informed about data use and re-use; personal identifiers are removed and study data are stored on encrypted, password-protected servers. Access will be provided after primary results publication, subject to a reasonable request and a data use agreement consistent with GDPR; supporting documents (protocol, SAP, blank CRFs) and code will also be shared.
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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.
5 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 Levothyroxine in people with Obesity, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 5 sites in Spain.
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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (kg) from baseline to Month 3 (time frame: Baseline to Month 3 (12 weeks ±2)). The study lists 2 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 12 Jan 2026.