Tirzepatide for Weight Loss Maintenance in Obesity

Not currently recruiting at 24 trial locations

Overseen By Madhavi Rudraraju

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Diabetes, Pancreatitis, Cardiovascular, Depression, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tirzepatide to determine its effectiveness in helping people maintain weight loss. The study compares tirzepatide to a placebo (a look-alike with no active medicine) to assess its effectiveness and safety. It seeks participants who have struggled with obesity, specifically those with a BMI over 30 or over 27 with conditions like high blood pressure or sleep apnea. Participants should also have previously attempted and not succeeded with a weight loss diet. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tirzepatide is generally well-tolerated. In one study, adults who were obese or overweight and did not have diabetes used tirzepatide, and the results indicated that the drug is safe for use. However, some participants experienced side effects, mostly related to the stomach and intestines, such as nausea or diarrhea.

Another study found that tirzepatide might reduce the risk of serious health problems, like heart and kidney issues. However, like other drugs in its class, rare but serious side effects can occur.

Tirzepatide is already approved for treating type 2 diabetes, which supports its safety. It is important to consider both the benefits and risks before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for obesity?

Researchers are excited about tirzepatide for obesity because it offers a fresh approach to weight management. Unlike traditional treatments that primarily focus on appetite suppression or fat absorption, tirzepatide is a dual-action drug that targets both GLP-1 and GIP receptors, hormones involved in regulating blood sugar and appetite. This dual mechanism may enhance weight loss more effectively and sustainably than current options. Additionally, tirzepatide is administered via a simple subcutaneous injection, which could offer convenience for patients managing chronic obesity.

What evidence suggests that tirzepatide might be an effective treatment for obesity?

Research has shown that tirzepatide helps people lose weight. One study found that participants taking tirzepatide lost more weight than those taking a placebo, a pill with no active ingredients. In this trial, participants will receive either tirzepatide or a placebo. Tirzepatide affects two parts of the body that control hunger and digestion, potentially leading to greater weight loss. Another study found tirzepatide more effective at reducing body weight and waist size than semaglutide, another weight loss drug. Overall, tirzepatide has proven effective for significant weight loss. ^{1 3 4 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with obesity or overweight who have related health issues like high blood pressure, sleep apnea, or heart disease. They should have tried to lose weight before without success. People with severe depression, diabetes, recent major heart problems, significant weight changes in the last 3 months, pancreatitis, or a family history of certain thyroid cancers cannot join.

Inclusion Criteria

My BMI is over 27 and I have a weight-related health issue like high blood pressure or heart disease.

You have previously attempted to reduce your body weight unsuccessfully.

Exclusion Criteria

I have diabetes and a history of severe diabetic complications.

I haven't had severe depression or serious mental health issues in the last 2 years.

I have lost or gained more than 5 kg in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weight-Loss Period

Participants complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose

60 weeks

Weight Maintenance Period

Participants enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD, or placebo

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tirzepatide

Trial Overview The study tests Tirzepatide's ability to help maintain weight loss compared to a placebo (a treatment with no active drug). Participants will be randomly assigned to receive either Tirzepatide or the placebo and monitored for effectiveness and safety.

How Is the Trial Designed?

Group I: Tirzepatide Maximum Tolerated Dose Experimental Treatment 1 Intervention

Participants will receive tirzepatide SC.

Group II: Tirzepatide 5 milligram (mg) Experimental Treatment 1 Intervention

Participants will receive tirzepatide subcutaneously (SC).

Group III: Placebo Placebo Group 1 Intervention

Participants will receive placebo.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Tirzepatide, a dual GIP and GLP-1 receptor agonist, showed greater improvements in glucose control and weight loss compared to the GLP-1 receptor agonist dulaglutide in a study involving 316 participants with type 2 diabetes.

The improvements in insulin sensitivity and beta-cell function with tirzepatide were only partially linked to weight loss, indicating that its dual receptor action provides unique mechanisms for better glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual GIP and GLP-1 Receptor Agonist Tirzepatide Improves Beta-cell Function and Insulin Sensitivity in Type 2 Diabetes. Thomas, MK., Nikooienejad, A., Bray, R., et al.[2022]

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]

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, a dual GIP and GLP-1 receptor agonist, showed significant reductions in Hemoglobin A1c levels (up to 3.02%) and weight loss in adults with uncontrolled type 2 diabetes, outperforming both placebo and active comparators like semaglutide.

The safety profile of tirzepatide was comparable to semaglutide regarding gastrointestinal adverse effects, and it did not increase the incidence of major cardiovascular events compared to insulin glargine, indicating it may be a valuable addition to diabetes treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice. Bradley, CL., McMillin, SM., Hwang, AY., et al.[2023]

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 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]

In a study of 579 adults with obesity, tirzepatide significantly enhanced weight loss after a 12-week lifestyle intervention, achieving an average additional weight reduction of 18.4% compared to just 2.5% with placebo over 72 weeks.

The treatment was well-tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating that tirzepatide is a safe and effective option for further weight management in individuals who have already lost weight through lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Wadden, TA., Chao, AM., Machineni, S., 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]

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]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206038

Tirzepatide Once Weekly for the Treatment of Obesity A molecule that combines both GIP and GLP receptor agonism theoretically may lead to greater efficacy in weight reduction. Tirzepatide is a once ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12313391/

Weight Loss Efficacy of Tirzepatide Compared to Placebo or ... Tirzepatide's dual action on glucose-dependent insulinotropic peptide (GIP) and GLP-1 receptors may offer additive benefits in terms of weight reduction.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2416394

Tirzepatide as Compared with Semaglutide for ... Treatment with tirzepatide was superior to treatment with semaglutide with respect to reduction in body weight and waist circumference at week 72.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2667368124000299

Weight loss outcomes, tolerability, side effects, and risks Effective Weight Loss: GLP-1 RAs like liraglutide, semaglutide, and tirzepatide lead to significant weight loss, with tirzepatide being the most effective. •.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822209

Clinical Outcomes of Tirzepatide or GLP-1 Receptor ... Treatment with tirzepatide was associated with significantly lower hazards of all-cause mortality and major adverse cardiovascular and kidney events compared ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK585056/

Tirzepatide - StatPearls - NCBI Bookshelf However, the clinical data have shown that weight reduction appears to be dose-dependent; weight loss management may be limited by the ability of the ...

7. uchicagomedicine.org uchicagomedicine.org/forefront/research-and-discoveries-articles/2024/may/research-on-glp-1-drugs

Research shows GLP-1 drugs are effective but complex Physicians and researchers agree that the drugs are highly effective for weight management and Type 2 diabetes treatment.