Olatorepatide for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, olatorepatide, to determine its safety and effectiveness for treating individuals who are overweight or obese without diabetes. Researchers aim to identify any side effects, assess the drug's efficacy, and understand how the body processes it. They also seek to determine if the body produces antibodies against the drug, which might reduce its effectiveness. The trial is suitable for individuals with a body mass index (BMI) between 27 and 45 who have not experienced diabetes or significant weight changes recently. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that olatorepatide is likely to be safe for humans?
Previous studies have shown that olatorepatide is safe for people with diabetes. Research indicates that stomach issues are the most common side effects, occurring more frequently at higher doses. Although rare, some serious side effects have been reported, but they remain uncommon. This treatment is still under investigation, and further information will enhance understanding of its safety.12345
Why do researchers think this study treatment might be promising for obesity?
Olatorepatide is unique because it offers a new approach to treating obesity by potentially targeting specific pathways in the body that regulate appetite and metabolism. Unlike the standard treatments for obesity, which often include lifestyle changes or medications like orlistat and phentermine that focus on reducing fat absorption or suppressing appetite, Olatorepatide may work on a deeper biological level. Researchers are excited about this treatment because it could offer a more effective and long-lasting solution for weight management by directly influencing the body’s energy balance mechanisms.
What evidence suggests that olatorepatide might be an effective treatment for obesity?
Research has shown that olatorepatide can be effective for weight loss. In earlier studies, participants who took olatorepatide lost up to 19% of their body weight over 48 weeks. This significant weight loss indicates a meaningful change for many participants. The drug helps control appetite and metabolism. These findings suggest that olatorepatide could be a promising option for those struggling with obesity. Participants in this trial will join either the General Cohort or the Subgroup Cohort, both receiving olatorepatide as part of the study.24678
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults in the US who are overweight or obese (BMI between 27 and 45), do not have diabetes, and can follow study instructions. People with recent major weight changes, past or planned weight loss surgery, certain pancreas or gallbladder problems, or a history of cancer within the last 5 years cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive olatorepatide or placebo to assess safety, tolerability, and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Olatorepatide
Trial Overview
The study compares olatorepatide (a new drug) to a placebo to see how safe it is, how well it works for people with overweight or obesity without diabetes, and how the body processes the drug. Participants are randomly assigned to receive either olatorepatide or placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Citations
1.
fiercebiotech.com
fiercebiotech.com/biotech/regenerons-obesity-drug-shows-zepbound-efficacy-phase-3Regeneron's obesity drug shows Zepbound-like efficacy in ...
At Week 48, Hansoh reported mean weight loss of up to 19.3% in the olatorepatide cohorts. The result supports the claim the drug candidate has ...
2.
regeneronpharmaceuticalsinc.gcs-web.com
regeneronpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/olatorepatide-obesity-treatment-licensed-regeneron-demonstratesOlatorepatide Obesity Treatment Licensed by Regeneron ...
Patients treated with olatorepatide achieved up to 19% body-weight loss at week 48. Regeneron's global Phase 3 registrational program to be initiated later ...
3.
linkedin.com
linkedin.com/posts/garrett-overcast_olatorepatide-obesity-treatment-licensed-activity-7436745235763851264-JOZTRegeneron's Olatorepatide Hits 19% Mean Weight Loss in ...
Breaking News: Regeneron says its in-licensed dual GLP-1/GIP agonist hit up to 19% mean weight loss in a Phase 3 obesity trial Bottom line: ...
Olatorepatide (HS-20094) Achieves Up to 19.3% Weight ...
Olatorepatide achieved up to 19.3% body-weight loss at Week 48, with a high proportion of participants achieving clinically meaningful weight-loss.
Regeneron touts Chinese Phase III data for obesity hopeful ...
The weight-loss candidate also had lower treatment discontinuation rates compared with published Phase III data for other incretin drugs. Go ...
6.
investor.regeneron.com
investor.regeneron.com/news-releases/news-release-details/olatorepatide-obesity-treatment-licensed-regeneron-demonstratesOlatorepatide Obesity Treatment Licensed by ...
Patients treated with olatorepatide achieved up to 19% body-weight loss at week 48. Regeneron's global Phase 3 registrational program to be initiated later ...
olatorepatide (HS-20094) / Jiangsu Hansoh Pharma, ...
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US ... Research data show that in diabetic patients, HS-20094 is safe and ...
Olatorepatide for Obesity
This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this ...
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