GZR18 vs Tirzepatide for Obesity

Recruiting at 36 trial locations

Overseen By Kimberly Lazaroff

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Gan and Lee Pharmaceuticals, USA

Must not be taking: Antidepressants, Antipsychotics, Mood stabilizers, others

Disqualifiers: Diabetes, Renal impairment, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 20

Duration: 36 weeks

285 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase 2 study to evaluate the safety and efficacy of 24, 36, and 48 mg GZR18 (Q2W) compared with placebo and 15 mg tirzepatide (QW). The study will evaluate weight management in participants with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with weight-related comorbidities (excluding type 2 diabetes mellitus).

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, certain medications that cause weight gain or are intended for weight loss are not allowed, and some medications must have stable doses for 30 days before screening. It's best to discuss your specific medications with the trial team.

Is tirzepatide safe for humans?

Tirzepatide has been tested in several clinical trials for type 2 diabetes and obesity, showing common side effects like nausea, vomiting, diarrhea, and constipation, especially at higher doses. It has been found to be generally safe for the heart, with no increased risk of major cardiovascular events. ^{1 2 3 4 5}

How is the drug tirzepatide unique for treating obesity?

Tirzepatide is unique because it combines two actions in one drug, targeting both the GLP-1 and GIP receptors, which helps control blood sugar and reduce appetite, leading to significant weight loss. This dual action makes it more effective than some other treatments and offers an alternative to bariatric surgery for obesity. ^{2 4 6 7 8}

What data supports the effectiveness of the drug tirzepatide for obesity?

Research shows that tirzepatide, a drug that works on specific hormones to help control blood sugar and appetite, is effective for weight loss in people with obesity and type 2 diabetes. Studies found that it leads to significant weight loss and improves other health markers like blood pressure and fat levels. ^{2 4 7 9 10}

Are You a Good Fit for This Trial?

This trial is for adults who are obese (BMI ≥30) or overweight (BMI ≥27) with weight-related health issues, but not type 2 diabetes. Participants should be seeking treatment for weight management.

Inclusion Criteria

History of failing to lose sufficient weight with lifestyle/dietary modification

I am willing and able to self-inject the treatment and follow the study's procedures.

My BMI is 30 or higher, or it's 27 or higher with certain conditions.

Exclusion Criteria

I do not have a history of severe depression or psychiatric disorders.

History of suicide attempt or high PHQ-9 score

Laboratory values suggestive of diabetes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive GZR18 or placebo every 2 weeks, or tirzepatide every week, for weight management

36 weeks

Bi-weekly visits (in-person) for GZR18 and placebo, weekly visits for tirzepatide

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• GZR18
• Tirzepatide

Trial Overview The study tests different doses of GZR18 given every two weeks against Tirzepatide given weekly and a placebo to see which is better at managing weight in participants.

How Is the Trial Designed?

Group I: 48 mg GZR18 group Experimental Treatment 1 Intervention

48 mg GZR18 group: 76 participants (57 receiving GZR18 and 19 receiving placebo)

Group II: 36 mg GZR18 group Experimental Treatment 1 Intervention

36 mg GZR18 group: 76 participants (57 receiving GZR18 and 19 receiving placebo)

Group III: 24 mg GZR18 group Experimental Treatment 1 Intervention

24 mg GZR18 group: 76 participants (57 receiving GZR18 and 19 receiving placebo)

Group IV: Tirzepatide group Active Control 1 Intervention

Tirzepatide group: 57 participants receiving 15 mg tirzepatide

Who Is Running the Clinical Trial?

Gan and Lee Pharmaceuticals, USA

Lead Sponsor

Trials

27

Recruited

3,200+

Published Research Related to This Trial

Tirzepatide, a once-weekly medication for type 2 diabetes, not only improves blood sugar control but also leads to significant weight loss and positive changes in cardiovascular health, such as reduced blood pressure and improved insulin sensitivity.

The weight loss and metabolic benefits of tirzepatide are linked to its dual action as a GIP and GLP-1 receptor agonist, suggesting that these mechanisms play a crucial role in its effectiveness for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on weight control in diabetes - Tirzepatide. Várkonyi, TT., Pósa, A., Pávó, N., et al.[2023]

Tirzepatide demonstrated a dose-dependent ability to lower HbA1c levels in adults with type 2 diabetes, with reductions ranging from -17.71 to -22.35 mmol/mol compared to placebo, and was also more effective in reducing body weight than other treatments.

While tirzepatide did not increase the risk of hypoglycaemia compared to placebo and showed lower rates than basal insulin, it was associated with a higher incidence of gastrointestinal side effects, particularly nausea and vomiting, especially at the 15 mg dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. Karagiannis, T., Avgerinos, I., Liakos, A., et al.[2023]

In a systematic review of randomized controlled trials involving 5800 patients, tirzepatide was found to be highly effective for weight loss, with 78.22% achieving at least 5% weight loss and 32.28% achieving at least 15% weight loss.

Tirzepatide demonstrated superior weight loss compared to placebo and semaglutide, with a significant mean weight loss of -12.47 kg at the 5 mg dose, while showing a manageable safety profile with only a slight increase in gastrointestinal adverse events compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. Tan, B., Pan, XH., Chew, HSJ., et al.[2023]

In a 72-week phase 3 trial involving 938 adults with obesity and type 2 diabetes, tirzepatide (10 mg and 15 mg) led to significant weight loss, with reductions of -12.8% and -14.7% respectively, compared to only -3.2% with placebo.

The safety profile of tirzepatide was generally favorable, with most adverse events being mild to moderate gastrointestinal issues, and serious adverse events were rare, indicating it is a safe option for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Garvey, WT., Frias, JP., Jastreboff, AM., et al.[2023]

Tirzepatide significantly reduces body weight in patients with type 2 diabetes and obesity, with an average weight loss of -9.81 kg compared to placebo, based on a meta-analysis of 10 studies involving 9,873 patients.

While tirzepatide is effective for weight loss, it has a higher incidence of gastrointestinal side effects compared to placebo, although serious adverse events and hypoglycemia are less common, indicating a need for monitoring these reactions during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss efficiency and safety of tirzepatide: A Systematic review. Lin, F., Yu, B., Ling, B., et al.[2023]

Tirzepatide, the first dual GIP/GLP-1 receptor co-agonist approved for type 2 diabetes, significantly reduces HbA1c levels (by 1.24 to 2.58%) and body weight (by 5.4-11.7 kg) in clinical trials involving type 2 diabetic patients, outperforming the selective GLP-1 RA semaglutide.

The safety profile of tirzepatide is similar to that of other GLP-1 receptor agonists, with common side effects including nausea and diarrhea, and it shows potential cardiovascular safety, as no significant increase in major adverse cardiovascular events was observed during the trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. Nauck, MA., D'Alessio, DA.[2022]

Tirzepatide is a novel medication that acts on both GIP and GLP-1 receptors, enhancing insulin secretion and reducing glucagon levels, which helps improve glycemic control in adults with type 2 diabetes mellitus (T2DM).

It received its first approval in the USA in May 2022 for T2DM treatment and is currently being studied for additional conditions like obesity, heart failure, and non-alcoholic steatohepatitis, indicating its potential for broader therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: First Approval. Syed, YY.[2022]

Tirzepatide, approved in 2022, is a novel treatment for type 2 diabetes that acts on both GLP-1 and GIP pathways, showing significant efficacy in lowering blood sugar levels and promoting weight loss in various patient groups.

Clinical trials, including the SURPASS and SURMOUNT studies, indicate that tirzepatide has a safety profile similar to traditional GLP-1 receptor agonists, with common gastrointestinal side effects, making it a promising option for patients needing better glycemic and weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: Clinical review of the "twincretin" injectable. Krauss, Z., Hintz, A., Fisk, R.[2023]

Tirzepatide, a dual GLP-1 and GIP receptor agonist recently approved by the FDA, shows significant effectiveness in controlling blood sugar levels in type 2 diabetes mellitus (T2DM), outperforming traditional treatments like insulin.

In addition to improving glycemic control, tirzepatide also promotes substantial weight loss, positioning it as a promising alternative to bariatric surgery for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The catcher in the gut: Tirzepatide, a dual incretin analog for the treatment of type 2 diabetes mellitus and obesity. Lempesis, IG., Liu, J., Dalamaga, M.[2022]

In a 72-week phase 3 trial involving 2539 adults with obesity, tirzepatide (5 mg, 10 mg, or 15 mg) resulted in significant weight loss, with mean reductions of -15.0%, -19.5%, and -20.9% respectively, compared to only -3.1% with placebo.

A high percentage of participants (85% to 91%) on tirzepatide achieved at least a 5% weight reduction, and many experienced improvements in cardiometabolic measures, although gastrointestinal side effects were the most common adverse events, mostly mild to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide Once Weekly for the Treatment of Obesity. Jastreboff, AM., Aronne, LJ., Ahmad, NN., et al.[2023]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Perspectives on weight control in diabetes - Tirzepatide. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Weight loss efficiency and safety of tirzepatide: A Systematic review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Tirzepatide: First Approval. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Tirzepatide: Clinical review of the "twincretin" injectable. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The catcher in the gut: Tirzepatide, a dual incretin analog for the treatment of type 2 diabetes mellitus and obesity. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide Once Weekly for the Treatment of Obesity. [2023]