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Tirzepatide for Obesity
(SURMOUNT-1 Trial)

No longer recruiting at 202 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Diabetes, Pancreatitis, Thyroid carcinoma, others

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

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the medication tirzepatide can aid weight loss in people with obesity. It evaluates the effectiveness of different doses of tirzepatide compared to a placebo (a substance with no active medication). The trial includes an initial phase of 72 weeks and, for some participants, an extension phase lasting an additional two years. Eligible participants should have a body mass index (BMI) of 30 or more, or 27 with weight-related health issues like high blood pressure, and have tried dieting without success. The trial excludes individuals with diabetes or certain other medical conditions. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new obesity treatment.

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

The trial information does not specify whether 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 effective for weight loss and reducing the risk of serious health issues. In studies, tirzepatide led to greater weight loss and waist size reduction compared to another weight loss drug, semaglutide, making it a promising option for weight management.

Regarding safety, tirzepatide is generally well-tolerated, though it can cause side effects similar to those of other medications. The most common side effects include stomach-related issues, such as nausea or diarrhea, which are usually mild but can be uncomfortable.

Serious side effects are rare but possible. Although uncommon, they have occurred in some cases. Since tirzepatide is already used for conditions like type 2 diabetes, extensive information about its safety is available. Prospective trial participants should discuss any concerns with the study team.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Researchers are excited about tirzepatide for obesity because it offers a unique approach compared to existing treatments. Unlike traditional options like lifestyle changes, medications such as orlistat, or GLP-1 receptor agonists like liraglutide, tirzepatide acts as a dual GIP and GLP-1 receptor agonist, which may enhance its effectiveness in reducing body weight. This dual action potentially leads to greater appetite suppression and improved metabolic control. The treatment is administered through weekly subcutaneous injections, providing a convenient dosing schedule. These features combined could make tirzepatide a promising new option for individuals struggling with obesity.

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

This trial will evaluate the effects of different doses of tirzepatide on weight loss in people with obesity. Participants will receive either 5 mg, 10 mg, or 15 mg of tirzepatide once a week, or a placebo. Studies have shown that tirzepatide aids weight loss in people with obesity, with significant weight loss observed in a 72-week study for those taking tirzepatide. Real-world evidence supports these findings, showing that people using tirzepatide noticed weight loss within six months. Continuing tirzepatide helps maintain weight loss, but stopping the treatment often leads to regaining weight. Overall, tirzepatide appears to be a promising option for obesity, offering lasting weight loss with ongoing use.⁶ ⁷ ⁸ ⁹ ¹⁰

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 who've tried to lose weight through dieting without success. They must have a BMI of at least 30, or over 27 with conditions like high blood pressure or sleep apnea. People with diabetes, recent significant weight changes, certain genetic disorders related to obesity, a history of pancreatitis or severe psychiatric issues in the last two years cannot join.

Inclusion Criteria

My BMI is over 27 and I have been diagnosed with a related health condition, or it is over 30.

You have tried to lose weight through dieting before, but it didn't work.

Exclusion Criteria

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

My obesity is caused by a hormonal disorder or a specific genetic condition.

I have a history of medullary thyroid cancer or MEN-2 in my family or myself.

See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Main Treatment

Participants receive tirzepatide or placebo once weekly for weight management

72 weeks

Extension

Participants with prediabetes continue treatment for additional monitoring

2 years

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 effects on body weight in overweight and obese individuals. It includes a placebo group for comparison and has two phases: an initial phase lasting 72 weeks and an extension phase spanning another two years for participants with prediabetes.

How Is the Trial Designed?

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 5 mg TirzepatideExperimental Treatment1 Intervention

* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5 mg tirzepatide dose SC QW until week 176. * Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.

Group II: 15 mg TirzepatideExperimental Treatment1 Intervention

* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 15 mg tirzepatide dose SC QW until week 176. * Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.

Group III: 10 mg TirzepatideExperimental Treatment1 Intervention

* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 10 mg tirzepatide dose SC QW until week 176. * Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.

Group IV: PlaceboPlacebo Group1 Intervention

* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received once weekly (QW) subcutaneous (SC) doses of a matching placebo, administered over a period of 72 weeks. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176. * Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.

Tirzepatide is already approved in United States, European Union, Canada, United Kingdom for the following indications:

Approved in United States as Mounjaro for:

Type 2 diabetes

Approved in European Union as Mounjaro for:

Type 2 diabetes

Approved in Canada as Mounjaro for:

Type 2 diabetes

Approved in United States as Zepbound for:

Weight loss
Moderate to severe obstructive sleep apnea

Approved in United Kingdom as Zepbound for:

Weight loss

Find a Clinic Near You

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 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, 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, 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]

Citations

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

Tirzepatide Once Weekly for the Treatment of ObesityIn this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body ...

2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39996368/

Real-world use and effectiveness of tirzepatide among ...While tirzepatide dose escalation was slower than in clinical trials, individuals achieved weight reduction at 6 months, consistent with ...

3.jamanetwork.comjamanetwork.com/journals/jama/fullarticle/2812936

Continued Treatment With Tirzepatide for Maintenance of ...In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and ...

4.sciencedirect.comsciencedirect.com/science/article/pii/S126236362500031X

Real-world use and effectiveness of tirzepatide among ...In the current study, individuals who persisted on tirzepatide for 6 months experienced mean weight reduction of 12.9 % at 6 months post-index, although most ...

5.dom-pubs.onlinelibrary.wiley.comdom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16290

Real‐world use and effectiveness of tirzepatide among ...While tirzepatide dose escalation was slower than in clinical trials, individuals achieved weight reduction at 6 months, consistent with ...

6.nejm.orgnejm.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.

7.ncbi.nlm.nih.govncbi.nlm.nih.gov/books/NBK585056/

Tirzepatide - StatPearls - NCBI BookshelfThis medication also demonstrates efficacy in weight loss, leading to its off-label use for obesity treatment. Tirzepatide is a dual agonist for the glucagon- ...

8.jamanetwork.comjamanetwork.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 ...

9.clinicaltrials.govclinicaltrials.gov/study/NCT05822830

NCT05822830 | A Study of Tirzepatide (LY3298176) in ...The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity ...

10.sciencedirect.comsciencedirect.com/science/article/pii/S2667368124000299

Weight loss outcomes, tolerability, side effects, and risksGLP-1RAs are effective in managing obesity, their use is associated with gastrointestinal side effects and rare but serious adverse events.

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