An interventional study of Tirzepatide (Per-label titration) and Tirzepatide (Flexible titration) in Obesity, sponsored by Dasman Diabetes Institute. Recruiting at 1 site in Kuwait. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Dasman Diabetes Institute · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to determine whether a flexible, symptom-guided titration strategy for tirzepatide can help adults with obesity without diabetes stay on treatment longer, while maintaining weight-loss effectiveness. The main questions it aims to answer are:
Researchers will compare standard per-label titration with a click-based, symptom-guided titration approach to assess differences in treatment persistence, tolerability, and effectiveness.
Participants will:
This study addresses the lack of evidence for individualized titration strategies in obesity treatment and aims to improve tolerability, treatment persistence, and long-term treatment outcomes.
Tirzepatide is an effective treatment for obesity, but gastrointestinal adverse events during dose escalation may limit tolerability and lead to early treatment discontinuation. Current labeling recommends a fixed titration schedule that does not account for individual differences in symptom tolerance. Evidence supporting individualized titration strategies in obesity treatment remains limited.
This randomized clinical trial aims to evaluate whether a flexible, symptom-guided titration strategy for tirzepatide can prolong time on treatment while maintaining weight-loss effectiveness in adults with obesity without diabetes. Participants will be randomly assigned to either standard per-label titration or a flexible, click-based titration approach that allows smaller dose increments based on individual tolerability.
Participants in the standard group will follow the approved fixed dose-escalation schedule, while participants in the flexible group will advance doses according to gastrointestinal symptom severity, with the goal of minimizing nausea and vomiting. All participants will attend study visits over 76 weeks for assessment of treatment persistence, weight change, gastrointestinal tolerability, safety, and adherence.
The primary outcome is time to discontinuation of the treatment regimen over 76 weeks, analyzed as restricted mean time on treatment. Secondary outcomes include the incidence of gastrointestinal adverse events (including nausea and vomiting) and weight change. Participants currently using, or who have used within 90 days before screening, medications that may increase or reduce body weight will be excluded.
This study aims to inform individualized dosing approaches that may improve treatment persistence and long-term obesity treatment outcomes.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 68 is close to the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Dasman Diabetes Institute is the lead sponsor of 31 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 20, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. History of type 1 or type 2 diabetes mellites. 2. Obesity-related:
Uncontrolled thyroid disease, defined as thyroid stimulating hormone >6.0 mIU/L or \<0.4 mIU/L as measured by the central laboratory at screening.
3. Mental health:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive tirzepatide with dose escalation according to the manufacturer's prescribing information.
Drug: Tirzepatide (Per-label titration)
Participants receive tirzepatide administered with a flexible dose escalation schedule.
Drug: Tirzepatide (Flexible titration)
Tirzepatide is administered by subcutaneous injection once weekly. Dose escalation follows the manufacturer's prescribing information, with advancement through labeled dose levels at prespecified intervals to the assigned maintenance dose
Tirzepatide is administered by subcutaneous injection once weekly. Dose escalation follows a flexible titration schedule as defined in the study protocol.
Time to discontinuation of the treatment regimen
Time from randomization to permanent discontinuation of the assigned tirzepatide titration regimen due to adverse events. Analyzed as restricted mean time on treatment (RMST), estimated as the area under the Kaplan-Meier curve up to 76 weeks and reported in weeks. Participants remaining on treatment at Week 76 are censored at that time. Higher values indicate longer time on treatment (better outcome).
Time frame: Randomization to Week 76
Exposure-adjusted rate of vomiting episodes assessed using the Modified Index of Nausea, Vomiting, and Retching (M-INVR)
Vomiting is assessed weekly using the validated M-INVR. The vomiting component is scored from 0 (no vomiting) to 4 (severe or frequent vomiting), with higher scores indicating worse outcomes. Vomiting burden will be summarized as weekly vomiting severity scores and as an exposure-adjusted rate (episodes per patient-week), calculated as the total number of vomiting episodes divided by each participant's total follow-up time
Time frame: Baseline to Week 76
Incidence, frequency, and duration of vomiting assessed using the MASCC Antiemesis Tool - Modified Index of Nausea and Vomiting (M-INVR)
Vomiting is assessed weekly using the MASCC Antiemesis Tool - Modified Index of Nausea and Vomiting (M-INVR), a validated patient-reported outcome measure. The vomiting subscale score is calculated as the sum of relevant vomiting items, with scores ranging from 0 to 16, where higher scores indicate greater incidence, frequency, and duration of vomiting (worse outcome).
Time frame: Baseline to Week 76
Change in body weight
Absolute and percentage change in body weight from baseline.
Time frame: Baseline to Week 76
Proportion of participants remaining on active study medication
Number of participants continuing to receive active study medication at the end of the trial.
Time frame: Week 76
Change in glycated hemoglobin (HbA1c)
Change in HbA1c from baseline.
Time frame: Baseline to Week 76
Change in lean body mass assessed by dual-energy X-ray absorptiometry (DEXA)
Change in total lean body mass measured by dual-energy X-ray absorptiometry (DEXA).
Time frame: Baseline to Week 76
Change in visceral adiposity assessed by dual-energy X-ray absorptiometry (DEXA)
Change in visceral adipose tissue measured by dual-energy X-ray absorptiometry (DEXA).
Time frame: Baseline to Week 76
Change in fat body mass assessed by dual-energy X-ray absorptiometry (DEXA)
Change in total fat body mass measured by dual-energy X-ray absorptiometry (DEXA).
Time frame: Baseline to Week 76
Change in Alanine Aminotransferase (ALT)
Change from baseline in serum alanine aminotransferase (ALT) levels in U/L, measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in Aspartate Aminotransferase (AST)
Change from baseline in serum aspartate aminotransferase (AST) levels in U/L, measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in Gamma-Glutamyl Transferase (GGT)
Change from baseline in serum gamma-glutamyl transferase (GGT) levels in U/L, measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in Alkaline Phosphatase (ALP)
Change from baseline in serum alkaline phosphatase (ALP) levels in U/L, measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in Fibrosis-4 (FIB-4) index
Change from baseline in the Fibrosis-4 (FIB-4) index, a composite score calculated as: FIB-4 = (Age × AST) / (Platelet count × √ALT), where age is measured in years, AST and ALT in U/L, and platelet count in 10⁹/L. The FIB-4 index is reported as a unitless value, with higher values indicating greater liver fibrosis. Values typically range from approximately 0 to 10.
Time frame: Baseline to Week 76
Change in Total Cholesterol
Change from baseline in fasting total cholesterol levels measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in Low-Density Lipoprotein Cholesterol (LDL-C)
Change from baseline in fasting low-density lipoprotein cholesterol (LDL-C) levels measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in High-Density Lipoprotein Cholesterol (HDL-C)
Change from baseline in fasting high-density lipoprotein cholesterol (HDL-C) levels measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in Triglycerides
Change from baseline in fasting triglyceride levels measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in estimated glomerular filtration rate (eGFR)
Change from baseline in estimated glomerular filtration rate (eGFR) calculated using a standard equation.
Time frame: Baseline to Week 76
Change in serum creatinine
Change from baseline in serum creatinine measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in urinary microalbumin
Change from baseline in urinary microalbumin concentration measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in urine albumin-to-creatinine ratio (ACR)
Change from baseline in urine albumin-to-creatinine ratio (ACR) measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in thyroid-stimulating hormone (TSH)
Change from baseline in serum thyroid-stimulating hormone (TSH) measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in free thyroxine (free T4)
Change from baseline in serum free thyroxine (free T4) measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in interleukin-6 (IL-6)
Change from baseline in circulating interleukin-6 (IL-6) concentration measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in interleukin-10 (IL-10)
Change from baseline in circulating interleukin-10 (IL-10) concentration measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in interleukin-1 receptor antagonist (IL-1Ra)
Change from baseline in circulating interleukin-1 receptor antagonist (IL-1Ra) concentration measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in tumor necrosis factor-alpha (TNF-α)
Change from baseline in circulating tumor necrosis factor-alpha (TNF-α) concentration measured using standard laboratory methods.
Time frame: Baseline to Week 76
Change in health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36)
Health-related quality of life is assessed using the 36-Item Short Form Health Survey (SF-36), a validated patient-reported outcome measure. The SF-36 yields an overall score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Baseline to Week 76
Change in dietary intake patterns
Changes in macronutrient composition and total caloric intake assessed using multiple-pass 24-hour dietary recalls.
Time frame: Baseline to Week 76
Incidence of adverse events and laboratory abnormalities
Incidence of treatment-emergent adverse events and clinically significant laboratory abnormalities.
Time frame: Baseline to Week 76
Change in retinal nerve fiber layer thickness assessed by optical coherence tomography (OCT)
Change from baseline in retinal nerve fiber layer thickness measured by optical coherence tomography
Time frame: Baseline to Week 76
Change in arterial stiffness measured by pulse wave velocity (PWV)
Change from baseline in arterial stiffness assessed by carotid-femoral pulse wave velocity.
Time frame: Baseline to Week 76
Change in sudomotor function assessed by Sudoscan
Change from baseline in sudomotor function measured by electrochemical skin conductance using Sudoscan.
Time frame: Baseline to Week 76
Treatment Persistence and Discontinuation
Treatment persistence will be assessed by the proportion of participants remaining on active study medication at week 76. Treatment discontinuation and reasons for discontinuation will be recorded throughout the study and categorized as gastrointestinal adverse events (including nausea and vomiting), other adverse events, lack of efficacy, participant preference, protocol non-adherence, loss to follow-up, pregnancy, investigator decision, or other specified reasons.
Time frame: Up to 76 weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tirzepatide
Dasman Diabetes Institute