Tirzepatide for Obesity

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
The Lundquist Institute, Torrance, CA
Obesity+2 More
Tirzepatide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help reduce the symptoms of heart failure.

See full description

Eligible Conditions

  • Obesity
  • Heart Failure With Preserved Ejection Fraction (HFpEF)

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Tirzepatide will improve 2 primary outcomes and 9 secondary outcomes in patients with Obesity. Measurement will happen over the course of Baseline, Week 24.

Baseline, Week 24
Change from Baseline in 6MWD
Baseline, Week 52
Change from Baseline in Exercise Capacity as Measured by 6MWD
Change from Baseline in the KCCQ CSS
Percent Change from Baseline in Body Weight Loss
Week 120
A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category
Time to First Occurrence of HF Events
Time to First Occurrence of HF Events or All-Cause Death
Time to First Occurrence of HF Events or Cardiovascular (CV) Death
Time to Recurrent Events of HF Events
Time to Recurrent Events of HF Events and CV Death
Week 52
Percentage of Participants with New York Heart Association (NYHA) Class Change

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

5 mg Tirzepatide
Nasopharyngitis
16%
Nausea
13%
Diarrhoea
12%
Vomiting
7%
Dyspepsia
7%
Decreased appetite
7%
Constipation
6%
Arthralgia
5%
Eructation
5%
Back pain
5%
Hypertension
3%
Flatulence
3%
Cardiac failure
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%
Cellulitis
0%
Peripheral arterial occlusive disease
0%
Aortic stenosis
0%
Respiratory failure
0%
Transient ischaemic attack
0%
Spinal stenosis
0%
Syncope
0%
Acute myocardial infarction
0%
Myocardial infarction
0%
Covid-19 pneumonia
0%
Transitional cell carcinoma
0%
Angina pectoris
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%
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%
Impaired healing
0%
Pulmonary embolism
0%
Pancreatic lesion excision
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%.

Trial Design

2 Treatment Groups

Tirzepatide
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 700 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tirzepatide is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Tirzepatide
Drug
Tirzepatide administered subcutaneously (SC)
Placebo
Other
Placebo administered SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: randomization (week 0) to study completion (estimated up to 120 weeks)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly randomization (week 0) to study completion (estimated up to 120 weeks) for reporting.

Closest Location

The Lundquist Institute - Torrance, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%
Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) > 200 pg/ml for participants without atrial fibrillation (AF), or >600 picogram/milliliter (pg/ml) for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure
Estimated glomerular filtration rate (eGFR) <70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening
Stable dose of heart failure medications within 4 weeks of screening
Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²)
6MWD 100-425m
KCCQ CSS ≤80

Patient Q&A Section

What is obesity?

"Obesity is defined as a body mass index (BMI >30 kg/m(2)) that is accompanied by increased risks of heart disease, diabetes, sleep problems, high-blood pressure and osteoarthritis, among others. It is among the leading modifiable risk factors associated with a range of chronic diseases. In men, the greater BMI, it is more likely than the lack of it, for the occurrence of high blood pressure, diabetes, and cardiovascular diseases. The BMI is significantly correlated with hyperinsulinaemia and increased insulin resistance. This correlation is higher in girls and the obese children than in the rest of the population." - Anonymous Online Contributor

Unverified Answer

Can obesity be cured?

"While dietary, lifestyle, and behavioral interventions can help to minimize weight gain, there is not enough evidence to show that they can actually cure obesity. As a result, clinicians and patient advocates should focus their efforts on treatment of obesity as a single priority." - Anonymous Online Contributor

Unverified Answer

What are the signs of obesity?

"In men, obesity is one of the leading risk factors for mortality. The most frequently used biomarkers (such as waist circumference, LDL-cholesterol and apolipoprotein B levels) as well as other potential new biomarkers (including leptin and inflammatory markers such as high sensitivity C-reactive protein) should be evaluated in further large prospective studies aiming at defining the most sensitive and specific biomarkers for obesity and the development of new diagnostic strategies." - Anonymous Online Contributor

Unverified Answer

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

"It is estimated that a baby will become diabetic in the United States every 18 seconds. Also, it is estimated that 2.7 million children and teenagers will develop eating disorders during a 5-year period. Obesity is one in every third child and it is believed to be the second most common chronic disease after childhood asthma. Obesity has received increasing attention in Western nations because of its association with chronic illnesses like hypertension and coronary artery disease." - Anonymous Online Contributor

Unverified Answer

What causes obesity?

"Obesity occurs due to alterations in energy balance, in which energy is more readily delivered to the adipose tissue than is required for use, whereas energy expenditure is generally reduced; however, in overweight individuals, the contribution of increased activity to adiposity may be greater than in leanness." - Anonymous Online Contributor

Unverified Answer

What are common treatments for obesity?

"Nearly 40% of people admitted to hospitals in the United States had an in-hospital episode of obesity or obesity-related obesity in 2006. The incidence of obesity and obesity-related diseases in the hospital has significantly decreased, while morbidity and mortality have increased. Obesity is a serious health problem; a large percentage of patients have serious comorbidities and are at risk for poor outcomes, including premature death. Given the substantial improvements in treating and preventing obesity, efforts should be made to educate patients and general practitioners on the health consequences of obesity and obesity-related problems." - Anonymous Online Contributor

Unverified Answer

Has tirzepatide proven to be more effective than a placebo?

"Tirzepatide 2.5 mg and 25 mg were superior to the placebo, but did not show superiority over the 100 μg formulation in achieving clinical improvement." - Anonymous Online Contributor

Unverified Answer

Does tirzepatide improve quality of life for those with obesity?

"The administration of tirzepatide was associated with a significant improvement in several HRQOL indices in those with obesity who are not considered candidates for bariatric surgery or restrictive dieting." - Anonymous Online Contributor

Unverified Answer

Is tirzepatide typically used in combination with any other treatments?

"In this exploratory study, tirzepatide in combination is well-tolerated in combination with other treatments. This clinical experience is consistent with the FDA's indication for the use of tirzepatide in combination with a balloon device in the treatment of patients with advanced gastrointestinal stromal tumors who have progression or complications following chemotherapy." - Anonymous Online Contributor

Unverified Answer

What does tirzepatide usually treat?

"Tirzepatripping is often overlooked while treating the patients with a variety of gastrointestinal and hepatobiliary conditions. Tirzepatidiomentous with pirfenidone appears to be an effective treatment of autoimmune hepatitis and liver fibrosis. Tirzepatization is also useful in the management of oesophagitis and oesophageal varices." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in tirzepatide for therapeutic use?

"Tirzepatide has a profound benefit of inducing tumour regression and reduces tumour size following its administration. The data have shown that these responses occur only in patients with the best prognostic factors including K-ras mutational status. Tirzepatide also shows a better response in K-ras (wt/wt) patients than in K-ras (wt/mutation) patients. Tirzepatide, therefore, may be especially useful for controlling a subset of patients who are treated with targeted therapy." - Anonymous Online Contributor

Unverified Answer

What is tirzepatide?

"It was efficacious in reducing %HbA1c in patients who had not achieved ≥7% or ≥8% HbA1c reduction at 48 weeks. While it is effective in patients with Type 2 diabetes, the side effects were usually tolerable, with no incidence of serious or life-threatening side effects." - Anonymous Online Contributor

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