Tirzepatide Maximum Tolerated Dose for Obesity

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Diabeteszentrum Hamburg West, Hamburg, Germany
Obesity+4 More
Tirzepatide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI-1 and those who are and plan to stay on PAP therapy in GPI-2.

Eligible Conditions

  • Obesity
  • Sleep Apnea

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Obesity

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Week 52

Week 52
A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 Score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score
Baseline, Week 52
Change from Baseline in High Sensitivity C reactive Protein (hsCRP) Concentration
Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour)
Change from Baseline in Systolic Blood Pressure (SBP)
Percent Change from Baseline in Apnea-Hypopnea Index (AHI)
Percent Change from Baseline in Body Weight
Week 52
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10
Percentage of Participants with ≥50% AHI Reduction from Baseline

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Obesity

Side Effects for

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

Trial Design

2 Treatment Groups

Tirzepatide Maximum Tolerated Dose
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

412 Total Participants · 2 Treatment Groups

Primary Treatment: Tirzepatide Maximum Tolerated Dose · Has Placebo Group · Phase 3

Tirzepatide Maximum Tolerated Dose
Drug
Experimental Group · 1 Intervention: Tirzepatide · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7080

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 52
Closest Location: Sleep Therapy Research Center · San Antonio, TX
Photo of San Antonio  1Photo of San Antonio  2Photo of San Antonio  3
2014First Recorded Clinical Trial
1 TrialsResearching Obesity
2 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
You have an AHI ≥15 on PSG as part of the trial at screening.
You have a body mass index (BMI) ≥30 kilogram/square meter (kg/m²).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.