ObesityPhase 4TRZNCT06009653
Effects of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
A Phase 4 study testing Culturally-tailored dietary and behavioral intensive lifestyle intervention and Tirzepatide in people with Obesity and Metabolic Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to conduct a three-arm 52-week, randomized controlled trial with double blind treatment to evaluate the effects of a drug called tirzepatide in combination with an innovative, culturally-appropriate, intensive lifestyle intervention (ILI) delivered by community health workers (CHWs) in… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Disease
- What is being tested?
- Culturally-tailored dietary and behavioral intensive lifestyle intervention and Tirzepatide
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2023to 29 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported Hispanic and/or Latino heritage
- Body Mass Index (BMI) 30-42 kg/m²
- HbA1c ≤ 6.4%
Who cannot join
- Previous diagnosis of diabetes or fasting glucose ≥ 126 mg/dl or 2 hr oral glucose tolerance test plasma glucose ≥ 200 mg/dl
- Unstable weight (≥4% during the last 2 months prior to study enrollment)
- CPAP treatment for obstructive sleep apnea
- Severe cardiovascular disease within the 6 months prior to study enrollment
- Severe organ system dysfunction
- Known clinically significant gastric emptying abnormality
Show all 24Show fewer
- History of chronic or acute pancreatitis
- Thyroid-stimulating hormone (TSH) >1.5X the upper limit of normal
- Medical conditions that cause obesity
- History of significantly active or unstable Major Depressive Disorder or other severe psychiatric disorder within the last 2 months
- Active substance abuse with alcohol or drugs
- Uncontrolled hypertension
- Liver disease
- Calcitonin level of ≥20 ng/L if eGFR ≥60 mL/min/1.73 m2 or ≥35 ng/L if eGFR <60 mL/min/1.73 m2
- Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- History of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
- Severe anemia
- Pregnant or breastfeeding
- Metal implants that preclude MRI testing
- Use of medications that are known to affect the study outcome measures
- Do not agree to use contraception throughout the study period in male and female participants of reproductive and childbearing age
- Persons who are not able to grant voluntary informed consent
- Unable or unwilling to follow the study protocol
- Have any other condition not listed in this section (e.g. hypersensitivity or intolerance) that is a contraindication of GLP-1R agonists
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Effect of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
The purpose of this study is to conduct a three-arm 52-week, randomized controlled trial with double blind treatment to evaluate the effects of a drug called tirzepatide in combination with an innovative, culturally-appropriate, intensive lifestyle intervention (ILI) delivered by community health workers (CHWs) in Latino adults with obesity. Participants will be randomized to 1) standard care (SC, n=25); 2) culturally-tailored dietary and behavioral intensive lifestyle intervention (ILI, n=25) provided by CHWs plus placebo; or 3) ILI plus tirzepatide (ILI-TRZ) for 52 weeks to evaluate the intervention's effect on: i) weight loss; ii) clinical efficacy (change in body fat mass, liver fat, intra-abdominal fat mass and intrahepatic triglyceride content, oral glucose tolerance, glycemic control, insulin sensitivity and b-cell function, plasma lipids, blood pressure, sleep duration, quality and behaviors, physical performance scores); iii) adherence and fidelity to the intervention (adherence to the intervention and barriers to long term adherence, quality-of-life, fidelity of the implementation by CHWs, CHW's and study participants' acceptability and satisfaction with the intervention and eating behaviors. Placebo or tirzepatide will be injected subcutaneously in the abdomen or thigh once a week for 12 months.
- Conditions
- Obesity, Metabolic Disease
- Being tested
- Standard Care, Culturally-tailored dietary and behavioral intensive lifestyle intervention, Placebo, Tirzepatide
- Keywords
- Latinos, Obesity, Plant-forward diet, Tirzepatide
- Medical subject headings
- Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareBehavioural
Participants will meet with community health workers to receive general health information through individual check-ins.
Culturally-tailored dietary and behavioral intensive lifestyle interventionBehavioural
Participants will meet with community health workers to receive information focused on healthy eating while still adhering to a culturally-tailored plant-forward diet.
PlaceboDrug
Participants will receive placebo subcutaneous injections.
TirzepatideDrug
Participants will receive subcutaneous injections of tirzepatide that gradually increase up to 15 mg per week.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | In this arm, participants will receive the standard care intervention from community health workers. Receives: Behavioral: Standard Care |
| Intensive lifestyle intervention plus placebo | Experimental | In this arm, participants will receive a culturally-tailored dietary and behavioral intensive lifestyle intervention from community health workers, and will receive placebo subcutaneous injections weekly during the 52-week intervention. Receives: Behavioral: Culturally-tailored dietary and behavioral intensive lifestyle intervention; Drug: Placebo |
| Intensive lifestyle intervention plus tirzepatide | Experimental | In this arm, participants will receive the behavioral plant-based intervention from community health workers, and will receive subcutaneous injections of tirzepatide weekly during the 52-week intervention Receives: Behavioral: Culturally-tailored dietary and behavioral intensive lifestyle intervention; Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Percent change in body weight
Measured: After 24 weeks of intervention
Change in body weight
Percent change in body weight
Measured: After 52 weeks of intervention
Secondary outcomes (33)
Proportion of participants losing at least 5% in body weight
Proportion of participants in each group that lose at least 5% in body weight
Measured: After 24 weeks of intervention
Proportion of participants losing at least 5% in body weight
Proportion of participants in each group that lose at least 5% in body weight
Measured: After 52 weeks of intervention
Proportion of participants losing at least 10% in body weight
Proportion of participants in each group that lose at least 10% in body weight
Measured: After 24 weeks of intervention
Proportion of participants losing at least 10% in body weight
Proportion of participants in each group that lose at least 10% in body weight
Measured: After 52 weeks of intervention
Proportion of participants losing at least 15% in body weight
Proportion of participants in each group that lose at least 15% in body weight
Measured: After 24 weeks of intervention
Proportion of participants losing at least 15% in body weight
Proportion of participants in each group that lose at least 15% in body weight
Measured: After 52 weeks of intervention
Fat mass and fat free mass
Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA)
Measured: Before and after 24 weeks of intervention
Fat mass and fat free mass
Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA)
Measured: Before and after 52 weeks of intervention
β-cell function
β-cell function will be assessed from a modified 3-hour oral glucose tolerance test
Measured: Before and after 24 weeks of intervention
β-cell function
β-cell function will be assessed from a modified 3-hour oral glucose tolerance test
Measured: Before and after 52 weeks of intervention
Insulin clearance
Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test
Measured: Before and after 24 weeks of intervention
Insulin clearance
Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test
Measured: Before and after 52 weeks of intervention
Plasma lipids
Fasting plasma lipid profile will be assessed by routine blood tests
Measured: Before and after 24 weeks of intervention
Plasma lipids
Fasting plasma lipid profile will be assessed by routine blood tests
Measured: Before and after 52 weeks of intervention
Blood pressure
Systolic and diastolic blood pressure will be measured
Measured: Before and after 24 weeks of intervention
Blood pressure
Systolic and diastolic blood pressure will be measured
Measured: Before and after 52 weeks of intervention
Sleep quality
Sleep quality will be assessed by polysomnography.
Measured: Before and after 24 weeks of intervention
Sleep quality
Sleep quality will be assessed by polysomnography.
Measured: Before and after 52 weeks of intervention
Sleep quantity
Sleep quantity will be assessed by polysomnography.
Measured: Before and after 24 weeks of intervention
Sleep quantity
Sleep quantity will be assessed by polysomnography.
Measured: Before and after 52 weeks of intervention
Liver fat
Liver fat will be assessed by using ultrasound
Measured: Before and after 24 weeks of intervention
Liver fat
Liver fat will be assessed by using ultrasound
Measured: Before and after 52 weeks of intervention
Intra-abdominal fat mass and intrahepatic triglyceride content
Intra-abdominal fat mass and intrahepatic triglyceride content will be assessed via magnetic resonance imaging (MRI)
Measured: Before and after 52 weeks of intervention
Physical performance
Physical performance will be measured as the time in seconds that takes to walk 50 ft and to stand up 5 times from a chair.
Measured: Before and after 24 weeks of intervention
Physical performance
Physical performance will be measured as the time in seconds that takes to walk 50 ft and to stand up 5 times from a chair.
Measured: Before and after 52 weeks of intervention
Grip strength
Grip strength will be measured using a hand dynamometer.
Measured: Before and after 24 weeks of intervention
Grip strength
Grip strength will be measured using a hand dynamometer.
Measured: Before and after 52 weeks of intervention
Lifestyle program adherence
Number of sessions attended
Measured: After 24 weeks of intervention
Lifestyle program adherence
Number of sessions attended
Measured: After 52 weeks of intervention
Drug/placebo adherence
Number of injections received
Measured: After 24 weeks of intervention
Drug/placebo adherence
Number of injections received
Measured: After 52 weeks of intervention
Program acceptability from community health workers and study participants
Community health workers' and study participants' perceptions of program acceptability via questionnaire
Measured: After 24 weeks of intervention
Program acceptability from community health workers and study participants
Community health workers' and study participants' perceptions of program acceptability via questionnaire
Measured: After 52 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start13 Sep 2023
- Primary completion29 May 2024
- Study completion29 May 2024
Why it stopped: The study was discontinued prematurely for administrative reasons
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.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Miriam Jacome Sosa, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009653
- Sponsor's protocol ID
- 202209182
- Other IDs
- P50MD017344
- Acronym
- TRZ
- Status last verified
- Feb 2025
- First submitted
- 19 Aug 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
- ClinicalTrials.gov ID
- NCT06009653
- Acronym / sponsor ID
- TRZ / 202209182
- Conditions
- Obesity, Metabolic Disease
- Keywords
- Latinos, Obesity, Plant-forward diet, Tirzepatide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was discontinued prematurely for administrative reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to conduct a three-arm 52-week, randomized controlled trial with double blind treatment to evaluate the effects of a drug called tirzepatide in combination with an innovative, culturally-appropriate, intensive lifestyle intervention (ILI) delivered by community health workers (CHWs) in Latino adults with obesity. Participants will be randomized to 1) standard care (SC, n=25); 2) culturally-tailored dietary and behavioral intensive lifestyle intervention (ILI, n=25) provided by CHWs plus placebo; or 3) ILI plus tirzepatide (ILI-TRZ) for 52 weeks to evaluate the intervention's effect on: i) weight loss; ii) clinical efficacy (change in body fat mass, liver fat, intra-abdominal fat mass and intrahepatic triglyceride content, oral glucose tolerance, glycemic control, insulin sensitivity and b-cell function, plasma lipids, blood pressure, sleep duration, quality and behaviors, physical performance scores); iii) adherence and fidelity to the intervention (adherence to the intervention and barriers to long term adherence, quality-of-life, fidelity of the implementation by CHWs, CHW's and study participants' acceptability and satisfaction with the intervention and eating behaviors. Placebo or tirzepatide will be injected subcutaneously in the abdomen or thigh once a week for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Standard CareIn this arm, participants will receive the standard care intervention from community health workers. |
| Intensive lifestyle intervention plus placebo | Experimental | Behavioral: Culturally-tailored dietary and behavioral intensive lifestyle intervention, Drug: PlaceboIn this arm, participants will receive a culturally-tailored dietary and behavioral intensive lifestyle intervention from community health workers, and will receive placebo subcutaneous injections weekly during the 52-week intervention. |
| Intensive lifestyle intervention plus tirzepatide | Experimental | Behavioral: Culturally-tailored dietary and behavioral intensive lifestyle intervention, Drug: TirzepatideIn this arm, participants will receive the behavioral plant-based intervention from community health workers, and will receive subcutaneous injections of tirzepatide weekly during the 52-week intervention |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-reported Hispanic and/or Latino heritage
- Body Mass Index (BMI) 30-42 kg/m²
- HbA1c ≤ 6.4%
Key exclusion criteria (24 listed)
- Previous diagnosis of diabetes or fasting glucose ≥ 126 mg/dl or 2 hr oral glucose tolerance test plasma glucose ≥ 200 mg/dl
- Unstable weight (≥4% during the last 2 months prior to study enrollment)
- CPAP treatment for obstructive sleep apnea
- Severe cardiovascular disease within the 6 months prior to study enrollment
- Severe organ system dysfunction
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 |
|---|---|---|
| Standard CareParticipants will meet with community health workers to receive general health information through individual check-ins. | Behavioural | Standard Care |
| Culturally-tailored dietary and behavioral intensive lifestyle interventionParticipants will meet with community health workers to receive information focused on healthy eating while still adhering to a culturally-tailored plant-forward diet. | Behavioural | Intensive lifestyle intervention plus placebo, Intensive lifestyle intervention plus tirzepatide |
| PlaceboParticipants will receive placebo subcutaneous injections. | Drug | Intensive lifestyle intervention plus placebo |
| TirzepatideParticipants will receive subcutaneous injections of tirzepatide that gradually increase up to 15 mg per week. | Drug | Intensive lifestyle intervention plus tirzepatide |
Primary outcome
Change in body weight
Time frame: After 24 weeks of intervention
Percent change in body weight
Change in body weight
Time frame: After 52 weeks of intervention
Percent change in body weight
33 secondary outcomes
Proportion of participants losing at least 5% in body weight
Time frame: After 24 weeks of intervention
Proportion of participants losing at least 5% in body weight
Time frame: After 52 weeks of intervention
Proportion of participants losing at least 10% in body weight
Time frame: After 24 weeks of intervention
Proportion of participants losing at least 10% in body weight
Time frame: After 52 weeks of intervention
Proportion of participants losing at least 15% in body weight
Time frame: After 24 weeks of intervention
Proportion of participants losing at least 15% in body weight
Time frame: After 52 weeks of intervention
Fat mass and fat free mass
Time frame: Before and after 24 weeks of intervention
Fat mass and fat free mass
Time frame: Before and after 52 weeks of intervention
β-cell function
Time frame: Before and after 24 weeks of intervention
β-cell function
Time frame: Before and after 52 weeks of intervention
Insulin clearance
Time frame: Before and after 24 weeks of intervention
Insulin clearance
Time frame: Before and after 52 weeks of intervention
Plasma lipids
Time frame: Before and after 24 weeks of intervention
Plasma lipids
Time frame: Before and after 52 weeks of intervention
Blood pressure
Time frame: Before and after 24 weeks of intervention
Blood pressure
Time frame: Before and after 52 weeks of intervention
Sleep quality
Time frame: Before and after 24 weeks of intervention
Sleep quality
Time frame: Before and after 52 weeks of intervention
Sleep quantity
Time frame: Before and after 24 weeks of intervention
Sleep quantity
Time frame: Before and after 52 weeks of intervention
Liver fat
Time frame: Before and after 24 weeks of intervention
Liver fat
Time frame: Before and after 52 weeks of intervention
Intra-abdominal fat mass and intrahepatic triglyceride content
Time frame: Before and after 52 weeks of intervention
Physical performance
Time frame: Before and after 24 weeks of intervention
Physical performance
Time frame: Before and after 52 weeks of intervention
Grip strength
Time frame: Before and after 24 weeks of intervention
Grip strength
Time frame: Before and after 52 weeks of intervention
Lifestyle program adherence
Time frame: After 24 weeks of intervention
Lifestyle program adherence
Time frame: After 52 weeks of intervention
Drug/placebo adherence
Time frame: After 24 weeks of intervention
Drug/placebo adherence
Time frame: After 52 weeks of intervention
Program acceptability from community health workers and study participants
Time frame: After 24 weeks of intervention
Program acceptability from community health workers and study participants
Time frame: After 52 weeks of intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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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.
Miriam Jacome Sosa principal investigator
Washington University School of Medicine
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 Culturally-tailored dietary and behavioral intensive lifestyle intervention and Tirzepatide in people with Obesity and Metabolic Disease, run by Washington University School of Medicine 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 3 inclusion and 24 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: withdrawn, as of the sponsor's last update on 25 Feb 2025. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 weight (time frame: After 24 weeks of intervention). 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 25 Feb 2025.