Zenagamtide + Tirzepatide for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how well the drug zenagamtide works for individuals who are overweight or have obesity and are already using tirzepatide. The goal is to determine the best dose of zenagamtide to switch to after tirzepatide. All participants will receive both drugs. It suits those who have maintained a stable dose of tirzepatide for at least four weeks, and some may also have type 2 diabetes managed with specific oral medications. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that tirzepatide is generally safe for most people. In studies, it helped many people lose weight and was usually well-tolerated. Most side effects were mild and mainly affected the stomach, such as nausea or diarrhea.
Detailed safety information for zenagamtide is not yet available. The trial is in the early stages, so researchers are still learning about its safety in humans. This phase is crucial for identifying any unexpected issues when people first use the treatment.
Researchers are testing these treatments together to determine their effectiveness and safety for weight management.12345Why are researchers excited about this trial's treatments?
Researchers are excited about tirzepatide and zenagamtide for obesity because they offer a fresh approach compared to existing treatments like lifestyle changes, medications such as orlistat, and surgical options like bariatric surgery. Tirzepatide is unique because it is a dual agonist, meaning it targets two different hormones that regulate insulin and appetite, potentially enhancing weight loss. Zenagamtide, on the other hand, offers a novel mechanism by acting as a gut hormone analog, which may help improve metabolism and reduce food intake. Together, these treatments could offer a more effective and convenient option for managing obesity, as they are administered via once-weekly injections, simplifying the treatment regimen.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that tirzepatide effectively aids weight loss in people with obesity. Studies found that participants using tirzepatide lost over 22% of their body weight on average and experienced significant improvements in body shape. Approximately 78% of participants lost at least 5% of their weight, with many losing even more. Although newer and less researched, zenagamtide is believed to help by reducing appetite and boosting metabolism. In this trial, participants will receive both tirzepatide and zenagamtide, aiming to provide a robust combined approach to managing obesity.678910
Who Is on the Research Team?
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
This trial is for adults who are overweight or have obesity, with or without type 2 diabetes, and are already taking tirzepatide. Participants must be able to safely switch from their current medication as determined by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tirzepatide followed by zenagamtide, each administered once weekly by subcutaneous injection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tirzepatide
- Zenagamtide
Trial Overview
The study tests how well people tolerate switching from tirzepatide to different doses of a new drug called zenagamtide. All participants will receive both medications during the trial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive one of the different dose levels of tirzepatide administered once weekly by subcutaneous injection. Following the last maintenance dose of tirzepatide, participants will switch to one of the different dose levels of zenagamtide administered once weekly by subcutaneous injection.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen
Citations
Weight Loss Dynamics and Health Burden Changes with ...
Patients treated with tirzepatide lost more weight than those treated with semaglutide (mean reduction, 14.7% vs. 10.8%; p<0.001).
Tirzepatide demonstrated significant and superior weight ...
Participants receiving tirzepatide had a total mean weight reduction of 24.3% from study entry after 12 weeks of intensive lifestyle ...
Effects of Tirzepatide on Body Composition, Metabolic ...
In this prospective real-world study, tirzepatide treatment over approximately one year resulted in consistent improvements across adiposity, ...
4.
pharmexec.com
pharmexec.com/view/tirzepatide-demonstrates-significant-benefits-patients-pre-diabetes-obesity-176-weeksTirzepatide Demonstrates Significant Benefits for Patients ...
Results found that tirzepatide achieved substantial average weight loss of 22.9% at the 15 mg dose, with 99% of participants remaining diabetes- ...
5.
sciety.org
sciety.org/articles/activity/10.22541/au.176402391.10613553/v1?utm_source=sciety_labs_article_pageEfficacy and Safety of Tirzepatide for the Management of Obesity
tirzepatide is an effective pharmacologic option for obesity treatment, demonstrating statistically significant reductions in mean body weight ...
Efficacy and Safety of Tirzepatide in Type 2 Diabetes ... - PMC
In people without diabetes, tirzepatide 5 to 15 mg once weekly for the treatment for obesity (SURMOUNT-1) resulted in substantial reductions in body weight ( ...
Efficacy and Safety of Tirzepatide and Semaglutide for ...
Tirzepatide and semaglutide were both associated with weight reduction in obesity, with greater reductions observed with tirzepatide, ...
Efficacy and safety of tirzepatide for weight loss in patients ...
Aggregated data indicated that tirzepatide treatment was correlated with higher likelihood of achieving ≥5% body weight loss comparing with ...
Review Comparative safety and side effects of semaglutide ...
[143] demonstrated that Tirzepatide followed by Semaglutide highly improved the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total scores that results ...
10.
drugdiscoverytrends.com
drugdiscoverytrends.com/novo-nordisks-new-weight-loss-treatment-inferior-to-lillys-tirzepatide/Novo Nordisk's new weight loss treatment inferior to tirzepatide
The treatment was safe and well tolerated, with mostly mild to moderate gastrointestinal adverse effects reported, consistent with other GLP-1s ...
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