← Trials/Trial dossier/NCT07574723

TiTRE

Not yet recruitingPhase NA

Tirzepatide Titration to Reduce Side Effects in Individuals With Obesity

Tirzepatide Titration to Reduce Side Effects (TiTRE) in Individuals With Obesity

Lead sponsor

Dasman Diabetes Institute

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Vomiting

Identifiers

Registered as

NCT IDNCT07574723

Org study IDRA HM-2026-06

Timeline

Milestones

Study first posted2026-05-08actual

Last update posted2026-05-08actual

Study start2026-05-15estimated

Primary completion2029-05-15estimated

Study completion2029-12-31estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age100 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Adults aged 18 years and older

2. A diagnosis of obesity (BMI ≥ 27 kg/m2) at screening with self-reported unsuccessful dietary efforts to lose weight.

3. No diagnosis of diabetes mellites.

4. Able to understand and sign the consent form

5. Able to undergo DEXA scan.

Exclusion criteria

•1. History of type 1 or type 2 diabetes mellites. 2. Obesity-related:

–A self-reported change in body weight >5 kg (11 lbs) within 90 days before screening irrespective of medical records.

–Treatment with any medication for the indication of obesity within the past 90 days before screening.

–Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed >1 year before screening; (2) lap banding, if the band has been removed >1 year before screening; (3) intragastric balloon, if the balloon has been removed >1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed >1 year before screening.

–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:

–History of major depressive disorder within 2 years before screening.

–Diagnosis of other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder).

–A Patient Health Questionnaire-9 score of ≥15 at screening.

–A lifetime history of a suicidal attempt.

–Suicidal behavior within 30 days before screening. 4. General safety:

–Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening.

–Presence of acute pancreatitis within the past 180 days prior to the day of screening.

–History or presence of chronic pancreatitis.

–Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

–Renal impairment measured as estimated glomerular filtration rate value of <15 mL/min/1.73 m2 as defined by KDIGO 2012 by the central laboratory at screening.

–History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.

–Any of the following: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within the past 60 days prior to screening.

–Subject presently classified as being in New York Heart Association Class IV.

–Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.

–Known or suspected abuse of alcohol or recreational drugs.

–Known or suspected hypersensitivity to trial product(s) or related products.

–Previous participation in this trial. Participation is defined as signed informed consent.

–Participation in another clinical trial within 90 days before screening.

–Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.

–Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.

Endpoints (33)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Safety / tolerability / PK

MASH / liver

Weight & body composition

Renal / kidney

Other (unclassified)

Other clinical outcomes

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Change in body weight

Time frame:Baseline to Week 76

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in lean body mass assessed by dual-energy X-ray absorptiometry (DEXA)

Time frame:Baseline to Week 76

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change in visceral adiposity assessed by dual-energy X-ray absorptiometry (DEXA)

Time frame:Baseline to Week 76

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change in fat body mass assessed by dual-energy X-ray absorptiometry (DEXA)

Time frame:Baseline to Week 76

Total fat mass

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Change in glycated hemoglobin (HbA1c)

Time frame:Baseline to Week 76

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

5 endpoints

Secondary/protocol endpoint

Change in Alanine Aminotransferase (ALT)

Time frame:Baseline to Week 76

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change in Aspartate Aminotransferase (AST)

Time frame:Baseline to Week 76

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Change in Gamma-Glutamyl Transferase (GGT)

Time frame:Baseline to Week 76

γ-GT, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Alkaline Phosphatase (ALP)

Time frame:Baseline to Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change in Fibrosis-4 (FIB-4) index

Time frame:Baseline to Week 76

change from baseline, improvement

Renal / kidney

4 endpoints

Secondary/protocol endpoint

Change in estimated glomerular filtration rate (eGFR)

Time frame:Baseline to Week 76

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in serum creatinine

Time frame:Baseline to Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change in urinary microalbumin

Time frame:Baseline to Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change in urine albumin-to-creatinine ratio (ACR)

Time frame:Baseline to Week 76

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

6 endpoints

Secondary/protocol endpoint

Change in Total Cholesterol

Time frame:Baseline to Week 76

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Low-Density Lipoprotein Cholesterol (LDL-C)

Time frame:Baseline to Week 76

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in High-Density Lipoprotein Cholesterol (HDL-C)

Time frame:Baseline to Week 76

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Triglycerides

Time frame:Baseline to Week 76

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in interleukin-6 (IL-6)

Time frame:Baseline to Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change in arterial stiffness measured by pulse wave velocity (PWV)

Time frame:Baseline to Week 76

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change in health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36)

Time frame:Baseline to Week 76

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Number of vomiting episodes per patient assessed using the Modified Index of Nausea, Vomiting, and Retching (M-INVR)

Time frame:From enrollment (at baseline) to the end of treatment at 76 weeks.

Vomiting

descriptive, event

Secondary/protocol endpoint

Incidence, frequency, and duration of vomiting assessed using the MASCC Antiemesis Tool - Modified Index of Nausea and Vomiting (M-INVR)

Time frame:Baseline to Week 76

Vomiting

descriptive, event

Secondary/protocol endpoint/low confidence

Proportion of participants remaining on active study medication

Time frame:Week 76

descriptive

Secondary/protocol endpoint

Change in thyroid-stimulating hormone (TSH)

Time frame:Baseline to Week 76

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Change in free thyroxine (free T4)

Time frame:Baseline to Week 76

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Incidence of adverse events and laboratory abnormalities

Time frame:Baseline to Week 76

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), laboratory abnormalities

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint/low confidence

Change in retinal nerve fiber layer thickness assessed by optical coherence tomography (OCT)

Time frame:Baseline to Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change in sudomotor function assessed by Sudoscan

Time frame:Baseline to Week 76

change from baseline, improvement

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Change in interleukin-10 (IL-10)

Time frame:Baseline to Week 76

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in interleukin-1 receptor antagonist (IL-1Ra)

Time frame:Baseline to Week 76

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in tumor necrosis factor-alpha (TNF-α)

Time frame:Baseline to Week 76

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in dietary intake patterns

Time frame:Baseline to Week 76

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.