LY3305677 for Obesity

Recruiting at 42 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eli Lilly and Company

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called LY3305677 to help adults who are obese or overweight manage their weight. The study will last over a year. Researchers want to see if this medication helps people lose weight and if it is safe to use.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants with hypertension should be on a stable antihypertensive regimen for at least 3 months prior to screening, suggesting that you may need to continue certain medications.

What data supports the idea that LY3305677 for Obesity is an effective drug?

The available research shows that LY3305677, also known as mazdutide, is effective in helping people lose weight. In a study with Chinese adults who were overweight or had obesity, those who took the drug for 24 weeks lost between 6.7% and 11.3% of their body weight, depending on the dose. In contrast, those who took a placebo, which is a dummy treatment with no active drug, only lost 1% of their body weight. This suggests that LY3305677 is much more effective than not taking any active treatment. ^{1 2 3 4 5}

What safety data is available for the obesity treatment LY3305677 (Mazdutide)?

Mazdutide (LY3305677) has been evaluated in clinical trials for its safety and efficacy in treating obesity. In a phase 1b trial, doses up to 9 mg and 10 mg were explored, while a phase 2 trial assessed doses up to 6 mg. The trials reported that mazdutide was well tolerated, with common adverse events including diarrhea, nausea, and upper respiratory tract infection. Overall, the treatment was considered safe and led to significant weight reduction in participants. ^{1 2 5 6 7}

Is the drug LY3305677 a promising treatment for obesity?

Yes, LY3305677, also known as mazdutide, is a promising drug for obesity. In studies, it helped people lose a significant amount of weight, with some losing up to 11.3% of their body weight over 24 weeks. This shows that it can be an effective option for weight management. ^{1 2 3 4 5}

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

Eligibility Criteria

This trial is for adults with obesity or overweight, having a BMI of at least 27 kg/m² and one weight-related health issue. Participants must have maintained stable body weight (less than 5% change) in the past three months and agree to follow reproductive safety measures.

Inclusion Criteria

You have a body mass index (BMI) of 27 or higher and at least one weight-related health issue, and your weight has been stable for the past 3 months with no significant gain or loss.

I agree to follow the study's rules about birth control and reproduction.

Treatment Details

Interventions

• LY3305677 (Other)
• Placebo (Other)

Trial Overview The study tests LY3305677 against a placebo over approximately 62 weeks to see if it's effective and safe for managing weight in obese or overweight adults. It follows a master protocol, meaning it's part of larger research efforts.

Participant Groups

Group I: LY3305677 Dose 3 Experimental Treatment 1 Intervention

Participants will receive LY3305677 SC.

Group II: LY3305677 Dose 2 Experimental Treatment 1 Intervention

Participants will receive LY3305677 SC.

Group III: LY3305677 Dose 1 Experimental Treatment 1 Intervention

Participants will receive LY3305677 subcutaneously (SC).

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive LY3305677 matching 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

Findings from Research

Mazdutide, a dual GLP-1 and glucagon receptor agonist, was well tolerated in a phase 1b trial with 24 participants, showing no serious adverse events and only mild to moderate treatment-emergent adverse events.

Participants receiving mazdutide experienced significant weight loss, with a mean reduction of 11.7% at 12 weeks for the 9 mg dose and 9.5% at 16 weeks for the 10 mg dose, compared to much smaller reductions in the placebo groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) 9 mg and 10 mg in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple-ascending-dose phase 1b trial. Ji, L., Gao, L., Jiang, H., et al.[2022]

In a 24-week study involving 248 overweight or obese adults in China, mazdutide, a dual GLP-1 and glucagon receptor agonist, resulted in significant weight loss, with reductions of up to 11.3% compared to a 1.0% increase in the placebo group.

Mazdutide was well tolerated across all doses, with common side effects including diarrhea, nausea, and upper respiratory infections, indicating a favorable safety profile for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity. Ji, L., Jiang, H., Cheng, Z., et al.[2023]

IBI362, a dual agonist for glucagon-like peptide-1 and glucagon receptors, was found to be well tolerated in a phase 1b study with 36 Chinese adults, showing no serious adverse events and only mild gastrointestinal issues as common side effects.

Participants receiving IBI362 experienced significant weight loss, with reductions of approximately 4.81% to 6.40% in body weight over 12 weeks, compared to a minimal change of 0.60% in the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study. Ji, L., Jiang, H., An, P., et al.[2022]

LY3437943 is a novel triple agonist that targets three receptors related to metabolism, showing promising results in obese mice by reducing body weight and improving blood sugar control.

In a phase 1 study, LY3437943 demonstrated a safety profile similar to existing treatments and supported once-weekly dosing, with weight loss effects lasting up to 43 days after a single dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss: From discovery to clinical proof of concept. Coskun, T., Urva, S., Roell, WC., et al.[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]

Liraglutide, a diabetes medication, has gained approval in both the US and Europe for obesity treatment and is expected to be widely accepted due to its efficacy.

New research is focusing on activating brown adipose tissue to enhance thermogenesis and developing drugs that mimic gut hormones to achieve results similar to bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Horizons in the Pharmacotherapy of Obesity. Arch, JR.[2018]

Weight loss through diet and exercise can significantly improve glycaemic control in early type 2 diabetes, and pharmacological options like sibutramine and thiazolidinediones are being explored for managing obesity in diabetic patients.

Thiazolidinediones, such as troglitazone, improve insulin resistance but have safety concerns, including severe liver injury, while newer agents like rosiglitazone and pioglitazone show promise with better safety profiles and are effective in combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promising new approaches. Reasner, CA.[2011]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) 9 mg and 10 mg in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple-ascending-dose phase 1b trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity. [2023]

3. England pubmed.ncbi.nlm.nih.gov

IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss: From discovery to clinical proof of concept. [2022]

5. England 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Horizons in the Pharmacotherapy of Obesity. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Promising new approaches. [2011]