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GLP/GIP Agonist

Tirzepatide for Obesity

Phase 2

Recruiting

Led By Tracey McLaughlin, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-70

Nondiabetic as defined by fasting plasma glucose < 126 mg/dL while off all glucose lowering medications

Must not have

Prior bariatric surgery or liposuction

Unstable body weight defined as self-reported weight change >2 kg over the past 6 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 6, and week 22

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study a new drug called tirzepatide to see if it can improve metabolic health in overweight or obese individuals by targeting fat cells. The drug is believed to promote weight loss

Who is the study for?

This trial is for adults aged 18-70 with obesity or overweight conditions. Overweight participants must have additional risk factors like hypertension, dyslipidemia, prediabetes, sleep apnea, fatty liver disease, gallstones, or osteoarthritis. Participants should not be diabetic and women can be pre or postmenopausal.

What is being tested?

The study tests Tirzepatide's effects on metabolic health in obese individuals by comparing it to a hypocaloric diet over 22 weeks. It aims to see if Tirzepatide improves fat distribution and insulin resistance beyond just weight loss through its dual action on GLP/GIP receptors in fat cells.

What are the potential side effects?

Potential side effects of Tirzepatide may include digestive issues such as nausea and diarrhea due to its effect on metabolism but specific side effects will be studied during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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My fasting blood sugar is below 126 mg/dL without diabetes medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had bariatric surgery or liposuction.

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My weight has been stable; I haven't lost or gained more than 2 kg in the last 6 weeks.

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My blood pressure is stable and not above 160/100 mm Hg.

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I do not have any major organ disease.

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I am currently receiving treatment for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 6, and week 22

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 6, and week 22

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6, and week 22 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess changes in Regional Fat

Change from baseline on the 2-stage Steady State Plasma Glucose test

Change in Adipocyte Fat Storage Capacity

+1 more

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032

40%

Diarrhoea

30%

Nausea

27%

Decreased appetite

23%

Upper respiratory tract infection

19%

Abdominal distension

11%

Vomiting

11%

Gastroenteritis

Flatulence

Abortion induced

Abdominal pain upper

Gingivitis

Amylase increased

Lipase increased

Abdominal pain

Injection site reaction

Menstruation irregular

Hepatic function abnormal

Hyperuricaemia

Uterine polyp

Vaginal infection

Dizziness

Hand fracture

Supraventricular tachycardia

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Tirzepatide

15 mg Tirzepatide

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 2.5 mg (up to 15 mg) TirzepatideExperimental Treatment1 Intervention

Patients assigned to tirzepatide will undergo dose titration starting with 2.5 mg per day with an increase every four weeks if tolerated by nausea. During the first 6 weeks, weight loss must be matched with the dietary weight loss arm at 0.6 kg/week. Participants will be seen every two weeks to review diet and physical activity, evaluate tolerability/side effects, and obtain morning weight. If weight loss is greater than 0.6 kg/week, recommendations to increase caloric intake will be made through the week 6 visits that repeat baseline testings (biopsy, metabolic tests, and regional fat scans). After the 6th week, weight loss can occur naturally without any restrictions (no further matching to the dietary weight loss group is required). Starting at week 8 the visits are decreased to every 4 weeks. Biopsies, metabolic tests, and regional fat scans are completed at baseline, week 6, and end of study (week 22).

Group II: Diet-controlledActive Control1 Intervention

The group assigned to dietary weight loss will undergo intensive dietary counseling with initial 3 day food diary evaluation followed by specific dietary recommendations that include macronutrient balanced, healthful and calorie-restricted diet, weekly dietitian visits, alternating between video and in person, use of a mobile app for food logging, weekly weights at home and biweekly weights, and review of these data by the study dietitian who will give individualized feedback at the weekly visits in order to attain targeted weight loss of 0.6 kg per week. The goal is to match weight loss in the tirzepatide and diet groups for the first six weeks. Any residual differences in weight loss at 6 weeks will be adjusted statistically. At six weeks all baseline tests (biopsy, metabolic tests, and regional fat scans) will be repeated, after which no further attempts for matching for weight loss will occur. At the end of the study (week 22), all baseline testing will occur again.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~7520

0 / 7Eligibility criteria met