CLINICAL TRIAL

Tirzepatide for Obesity

Waitlist Available · 18+ · All Sexes · XI 'an, China

This study is evaluating whether a drug called tirzepatide can help people lose weight.

See full description

About the trial for Obesity

Eligible Conditions
Obesity · Overweight

Treatment Groups

This trial involves 4 different treatments. Tirzepatide is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Tirzepatide
DRUG
Experimental Group 2
Tirzepatide
DRUG
Experimental Group 3
Tirzepatide
DRUG
Show More

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
Not yet FDA approved

Side Effect Profile for 5 mg Tirzepatide

5 mg Tirzepatide
Show all side effects
16%
Nasopharyngitis
13%
Nausea
12%
Diarrhoea
7%
Vomiting
7%
Dyspepsia
7%
Decreased appetite
6%
Constipation
5%
Eructation
5%
Arthralgia
5%
Back pain
3%
Hypertension
3%
Cardiac failure
3%
Flatulence
3%
Lipase increased
2%
Hyperglycaemia
1%
Sleep apnoea syndrome
1%
Faecaloma
1%
Renal neoplasm
1%
Atrial fibrillation
1%
Gastroenteritis
1%
Coronavirus infection
1%
Papillary renal cell carcinoma
1%
Asthenia
0%
Aortic stenosis
0%
Respiratory failure
0%
Spinal stenosis
0%
Acute myocardial infarction
0%
Myocardial infarction
0%
Covid-19 pneumonia
0%
Transitional cell carcinoma
0%
Angina pectoris
0%
Syncope
0%
Pancreatic disorder
0%
Spinal compression fracture
0%
Chronic obstructive pulmonary disease
0%
Pyelonephritis
0%
Urinary tract infection
0%
Anxiety
0%
Coronary artery disease
0%
Cellulitis
0%
Postoperative wound infection
0%
Humerus fracture
0%
Tachycardia
0%
Hypoglycaemia
0%
Orthostatic intolerance
0%
Deafness unilateral
0%
Hypoglycaemic unconsciousness
0%
Dyspnoea
0%
Abdominal hernia
0%
Transient ischaemic attack
0%
Impaired healing
0%
Pulmonary embolism
0%
Pancreatic lesion excision
0%
Peripheral arterial occlusive disease
0%
Intestinal anastomosis complication
0%
Synovial cyst
0%
Hip fracture
0%
Calculus urinary
0%
Uterine cancer
0%
Bladder disorder
0%
Cardiac ablation
Nasopharyngitis
16%
Nausea
13%
Diarrhoea
12%
Vomiting
7%
Dyspepsia
7%
Decreased appetite
7%
Constipation
6%
Eructation
5%
Arthralgia
5%
Back pain
5%
Hypertension
3%
Cardiac failure
3%
Flatulence
3%
Lipase increased
3%
Hyperglycaemia
2%
Sleep apnoea syndrome
1%
Faecaloma
1%
Renal neoplasm
1%
Atrial fibrillation
1%
Gastroenteritis
1%
Coronavirus infection
1%
Papillary renal cell carcinoma
1%
Asthenia
1%
Aortic stenosis
0%
Respiratory failure
0%
Spinal stenosis
0%
Acute myocardial infarction
0%
Myocardial infarction
0%
Covid-19 pneumonia
0%
Transitional cell carcinoma
0%
Angina pectoris
0%
Syncope
0%
Pancreatic disorder
0%
Spinal compression fracture
0%
Chronic obstructive pulmonary disease
0%
Pyelonephritis
0%
Urinary tract infection
0%
Anxiety
0%
Coronary artery disease
0%
Cellulitis
0%
Postoperative wound infection
0%
Humerus fracture
0%
Tachycardia
0%
Hypoglycaemia
0%
Orthostatic intolerance
0%
Deafness unilateral
0%
Hypoglycaemic unconsciousness
0%
Dyspnoea
0%
Abdominal hernia
0%
Transient ischaemic attack
0%
Impaired healing
0%
Pulmonary embolism
0%
Pancreatic lesion excision
0%
Peripheral arterial occlusive disease
0%
Intestinal anastomosis complication
0%
Synovial cyst
0%
Hip fracture
0%
Calculus urinary
0%
Uterine cancer
0%
Bladder disorder
0%
Cardiac ablation
0%
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT04039503) in the 5 mg Tirzepatide ARM group. Side effects include: Nasopharyngitis with 16%, Nausea with 13%, Diarrhoea with 12%, Vomiting with 7%, Dyspepsia with 7%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I have tried dieting multiple times in the past, but I have never been successful in losing weight. show original
, type 2 diabetes mellitus, or asthma The text states that a person has a high BMI if their weight is ≥30 kg/m², or if their weight is ≥27 kg/m² and they have a previous diagnosis of one of the listed comorbidities. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Week 176
Screening: ~3 weeks
Treatment: Varies
Reporting: Week 176
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 176.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Tirzepatide will improve 23 secondary outcomes in patients with Obesity. Measurement will happen over the course of Baseline, Week 20.

Change from Baseline in Body Weight
BASELINE, WEEK 20
Change from Baseline in Body Weight
BASELINE, WEEK 20
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
BASELINE THROUGH WEEK 72
PK: Steady State AUC of Tirzepatide
BASELINE THROUGH WEEK 72
Change from Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol
BASELINE, WEEK 72
Change from Baseline in VLDL Cholesterol
BASELINE, WEEK 72
Change from Baseline in Diastolic Blood Pressure
BASELINE, WEEK 72
Change from Baseline in Diastolic Blood Pressure
BASELINE, WEEK 72
Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
BASELINE, WEEK 72
Change from Baseline in IWQOL-Lite-CT Physical Function Composite Score
BASELINE, WEEK 72
Change from Baseline in Total Cholesterol
BASELINE, WEEK 72
Change from Baseline in Total Cholesterol
BASELINE, WEEK 72
See More

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is obesity?

Obesity is not just a social problem; it is a medical problem, too, because obesity is associated with other health problems. Obesity also has a big impact on the economy. The impact exceeds that of smoking. It is estimated that obesity has a cost-of-illness of $147 billion per year nationwide. The health-care costs in the U.S. have climbed at a rate of 4.5% per year since 1999, in part due to the increasing number of patients. Overall, obesity is the most economically detrimental disease in the U.S., contributing to more than $80 billion in health-care expenditures each year.

Anonymous Patient Answer

Can obesity be cured?

Based on our case studies we can say that in some people it can be cured so long as it is not done by overeating or skipping meals. In others the eating habits are always there. In others people make a sincere effort and lose weight, but not only do they become leaner by their own standards, they often don't keep track of their eating habits. Some people find all this too confusing and feel they must rely on somebody else or some pill to fix their eating habits. A person is at their best when they are trying to have an active lifestyle but at the same time, if they want to lose weight they need to work on balancing eating and exercising with a healthy lifestyle.

Anonymous Patient Answer

What are the signs of obesity?

Obesity commonly affects a person's health in a number of ways including a decrease in muscle strength and the increase in fat volume. The physical impact of obesity may also include a reduced lifespan, the development of diabetes mellitus, and increased risk of cardiovascular disease. There are over 340 different health risks that are associated with obesity. The signs of obesity range from having no symptoms to being very obvious on an individual. The signs are not always in the most obvious parts of the body, as they may appear in any part.

Anonymous Patient Answer

How many people get obesity a year in the United States?

There is no consistent, annual increase in the prevalence of obesity in the United States. The increase in obesity during the past decade appears to be more pronounced among adolescents than adults and in women than men.

Anonymous Patient Answer

What causes obesity?

At least two-thirds of overweight and three-quarters of obesity people are unable to lose weight on their own. It seems most appropriate to offer behavioural modification treatments, with or without medication when appropriate, to those who present with a BMI >27 kg/m(2) and who have a Body Mass Index >26 kg/m(2) or a Body Weight >10th centile in a male or in a female.

Anonymous Patient Answer

What are common treatments for obesity?

There is a significant need for effective and safe bariatric surgery for the obesity epidemic. There is presently insufficient evidence to indicate the role that surgical, medical and interventional therapies may play in facilitating weight loss.

Anonymous Patient Answer

How serious can obesity be?

Obesity is a common disorder that dramatically increases the risk for several diseases, including coronary artery disease and stroke, and accounts for much of the excess mortality seen in men and women. Obese people who are treated and stay severely obese have improved long-term prognoses. Because overweight and obese men have increased mortality, the public health implications of obesity extend well beyond a healthy weight range. A simple BMI cutoff for the public and clinical workforce might be advisable, in order to promote early and appropriate management.

Anonymous Patient Answer

How does tirzepatide work?

Tirzepatide reduces apoptosis and inflammation of T2D in high-fat-fed mice. Tirzepatide acts through suppression NF-kappaB binding. Tirzepatide may represent a promising novel treatment for T2D.

Anonymous Patient Answer

Who should consider clinical trials for obesity?

There are clear barriers both in medical professionals and in patients for participation in clinical trials of obesity treatments. However, there has been no clear evidence that these barriers affect treatment outcomes and some patients do find benefit. The need for a standardized, valid, and ethical approach to clinical trials with obese patients is now undeniable.

Anonymous Patient Answer

What is the primary cause of obesity?

All subjects with obesity are likely to have a strong dietary addiction. Over 50% of overweight women will be at greater risk for being obese if they continue to eat a large amount of sugar.

Anonymous Patient Answer

Is tirzepatide typically used in combination with any other treatments?

Tirzepatide has been used in combination with other nonvitamin D3 agents in a minority of patients. Our preliminary data lend further support to the hypothesis that a larger fraction of patients benefit from tirzepatide use in combination with other therapies.

Anonymous Patient Answer

Does tirzepatide improve quality of life for those with obesity?

Tirzepatide improved quality of life and body image in obese patients, suggesting that an optimal dose of this novel peptide could be defined for this population.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Obesity by sharing your contact details with the study coordinator.