LY3305677 for Obesity

No longer recruiting at 2 trial locations
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Overseen ByThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests LY3305677 (also known as Mazdutide, IBI362, or OXM-3), a new treatment to assess its safety and tolerance in individuals with obesity or overweight. Researchers will administer injections under the skin and observe the drug's interaction with the body. The trial includes a placebo group for comparison. It seeks participants who are generally healthy, have maintained stable weight for 3 months, and have a body mass index between 27 and 50. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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 trial coordinators or your doctor.

Is there any evidence suggesting that LY3305677 is likely to be safe for humans?

Research has shown that LY3305677, also known as mazdutide, is generally well-tolerated. Studies have found its safety profile similar to other drugs used to manage weight and blood sugar levels.

In other trials, researchers tested mazdutide at different doses, and participants responded well. The most common side effects, such as nausea or an upset stomach, are usually mild and typical for this type of medication.

This treatment remains in the early testing stages, so researchers continue to gather detailed safety information. However, current data suggests it is safe for use, with manageable and expected side effects.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for obesity and overweight, which often focus on lifestyle changes, medications like orlistat, or GLP-1 receptor agonists, LY3305677 is unique because it is administered subcutaneously. This delivery method might offer a more direct and potentially more effective way to manage weight. Researchers are excited about LY3305677 because it could offer a new mechanism of action, potentially leading to better outcomes for patients struggling with weight management. The excitement also stems from the possibility of addressing weight concerns with fewer side effects or complications compared to existing oral medications.

What evidence suggests that LY3305677 might be an effective treatment for obesity or overweight?

Research has shown that LY3305677, also known as mazdutide, could be a promising treatment for obesity. Studies have found that it works by activating two types of receptors in the body, aiding in weight reduction. In one study, many participants lost 10% or more of their body weight. Additionally, mazdutide helped control blood sugar levels, benefiting people with obesity. These findings suggest that LY3305677 could be an effective option for weight loss. Participants in this trial will receive either LY3305677 or a placebo to further evaluate its effectiveness.14678

Who Is on the Research Team?

C1

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?

Inclusion Criteria

Participants who are overtly healthy as determined by medical evaluation
Participants with stable weight for 3 months and body mass index of 27.0 and 50.0 kilograms per square meter (kg/m²)

Exclusion Criteria

Have history of type 1 diabetes mellitus or type 2 diabetes mellitus, ketoacidosis, or hyperosmolar state or coma

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of LY3305677 or placebo subcutaneously

20 weeks
Regular visits for injections and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY3305677
  • Placebo
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3305677Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

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 profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36247927/
Safety and efficacy of a GLP-1 and glucagon receptor dual ...High-dose mazdutide showed promising 12-week body weight loss, holding great potential for the treatment of moderate-to-severe obesity.
Once-Weekly Mazdutide in Chinese Adults with Obesity or ...Evidence suggests that incretin-based dual agonist pharmacotherapy is helpful in persons with obesity. Mazdutide, a glucagon-like peptide-1 ...
IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon ...This study is the first to report the safety, tolerability, pharmacokinetics and primary efficacy of a weekly-dose GLP-1 and glucagon receptor dual agonist in ...
Innovent's Mazdutide Shows Superiority in Glycemic ...The proportion of participants achieving HbA1c < 7.0% and a ≥10% reduction in body weight from baseline was 48.0% in the mazdutide group and ...
Mazdutide @ 2024 ADAAll above efficacy endpoints are 48-week results of mazdutide 6mg group (treatment-policy estimand), more data presented at 2024 ADA (1856 ...
Efficacy and Safety of Mazdutide in Chinese Patients With ...The safety profile of mazdutide was generally similar to those of GLP-1 receptor agonists and coagonists. These data support the future ...
Mazdutide (IBI362) Higher Dose 9mg Phase 2 Clinical ...Mazdutide 9mg demonstrated superior safety profile under leading weight loss efficacy and simple two-step titration dose regimen. Chinese ...
Mazdutide (IBI362, LY3305677, CAS NumberMazdutide. Item No. 40971. Mazdutide (IBI362, LY3305677, CAS Number: 2259884-03-0). Download Product Insert (PDF)Download Safety Data Sheet (SDS) (PDF). 1 mg ...
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