Orforglipron for Obesity

(ATTAIN-1 Trial)

Not currently recruiting at 194 trial locations

Overseen By Neda Rasouli

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Diabetes, Pancreatitis, Thyroid cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new pill, orforglipron, for individuals with obesity or those who are overweight with related health issues. The researchers aim to determine if this pill aids in weight loss and improves conditions such as high blood pressure or sleep apnea. Participants will receive varying doses of orforglipron or a placebo for comparison. Individuals who have struggled with weight loss and have conditions like high blood pressure or sleep apnea might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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 might be 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?

Studies have shown that orforglipron is generally well-tolerated. Research indicates that most people taking orforglipron experience only mild side effects, such as nausea or diarrhea, which are common with weight loss treatments. Orforglipron has also been tested for other conditions, like type 2 diabetes, and proved to be safe. Since this study is in a later phase, there is already some evidence that orforglipron is safe for humans. However, as with any treatment, discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about Orforglipron for obesity because it introduces a new approach to weight management with an oral administration method. Unlike many existing obesity treatments that require injections, Orforglipron is taken as a pill, which could make it more convenient and accessible for patients. Additionally, Orforglipron acts as a GLP-1 receptor agonist, which is a mechanism that helps regulate appetite and food intake, potentially offering a different pathway to effective weight loss compared to traditional options. This unique combination of oral delivery and its specific mechanism of action is why there's a lot of interest in its potential benefits.

What evidence suggests that orforglipron might be an effective treatment for obesity?

Studies have shown that orforglipron can help people with obesity lose weight. In earlier research, participants taking orforglipron lost up to 5.4 kg (about 12 pounds) in just four weeks. Another study found that after 72 weeks, people taking orforglipron lost about 12.4% of their body weight. These results suggest that orforglipron is quite effective for weight loss. It works by affecting hormones that control hunger and blood sugar, helping people eat less and lose weight. Participants in this trial will receive different doses of orforglipron or a placebo to evaluate its effectiveness further. ^{2 4 6 7 8}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 with obesity or overweight who also have weight-related health issues like high blood pressure, sleep apnea, heart disease, or high cholesterol. Participants should have a BMI of 30 or higher and a history of unsuccessful dieting to lose weight.

Inclusion Criteria

Have a BMI

≥30.0 kilogram/square meter (kg/m²)

I have high blood pressure, cholesterol issues, sleep apnea, or heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once daily oral orforglipron or placebo

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Orforglipron
• Placebo

Trial Overview The study is testing Orforglipron, an oral medication taken once daily, against a placebo to see if it's effective and safe in helping people with obesity or overweight reduce their body weight.

How Is the Trial Designed?

Group I: Orforglipron Dose 3 Experimental Treatment 1 Intervention

Participants will receive orforglipron administered orally.

Group II: Orforglipron Dose 2 Experimental Treatment 1 Intervention

Participants will receive orforglipron administered orally.

Group III: Orforglipron Dose 1 Experimental Treatment 1 Intervention

Participants will receive orforglipron administered orally.

Group IV: Placebo Placebo Group 1 Intervention

Participants will be given 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

Published Research Related to This Trial

A study involving adults with obesity demonstrated that the daily oral GLP-1 receptor agonist orforglipron effectively aids in weight loss, showcasing its potential as a treatment option for obesity.

The findings suggest that orforglipron may offer a convenient oral alternative to traditional injectable GLP-1 receptor agonists, enhancing patient adherence to obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In obesity or overweight without diabetes, orforglipron increased weight loss at 26 wk. Lau, D.[2023]

In a 12-week study involving 72 adults with type 2 diabetes, the multi-receptor agonist LY3437943 demonstrated a good safety profile, with gastrointestinal disorders being the most common side effects.

LY3437943 significantly reduced daily plasma glucose and HbA1c levels, as well as body weight, in a dose-dependent manner, supporting its potential for once-weekly dosing and further development in treating type 2 diabetes and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. Urva, S., Coskun, T., Loh, MT., et al.[2022]

In a 26-week phase 2 trial involving 383 participants with type 2 diabetes, orforglipron significantly reduced HbA1c levels by up to -2.10% compared to placebo and showed greater weight loss of up to -10.1 kg, indicating its efficacy as a treatment option.

The safety profile of orforglipron was comparable to other GLP-1 receptor agonists, with most adverse events being mild to moderate gastrointestinal issues, suggesting it may be a safer and more convenient alternative to injectable treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. Frias, JP., Hsia, S., Eyde, S., et al.[2023]

In a phase 2 trial involving 272 adults with obesity, the oral GLP-1 receptor agonist orforglipron resulted in significant weight loss, with participants losing between 8.6% to 14.7% of their body weight by week 36, compared to only 2.3% in the placebo group.

Orforglipron was generally well-tolerated, with mild to moderate gastrointestinal side effects being the most common adverse events, leading to discontinuation in 10-17% of participants, similar to the safety profile of injectable GLP-1 receptor agonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. Wharton, S., Blevins, T., Connery, L., et al.[2023]

In a Phase 1b trial involving 68 participants with type 2 diabetes, orforglipron (LY3502970) demonstrated significant reductions in HbA1c levels (by -1.5% to -1.8%) and body weight (by -0.24 to -5.8 kg) compared to placebo, which only showed a -0.4% change in HbA1c.

Orforglipron was generally well tolerated, with gastrointestinal side effects similar to those seen with other GLP-1 receptor agonists, suggesting it may be a safe and effective oral alternative to injectable treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1b, multicentre, blinded, placebo-controlled, randomized, multiple-ascending-dose study in people with type 2 diabetes. Pratt, E., Ma, X., Liu, R., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37344954/

Orforglipron (LY3502970), a novel, oral non-peptide ... Substantial reductions in body weight of up to 5.4 kg were observed after 4 weeks in orforglipron-treated participants, compared to a reduction ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06672939

NCT06672939 | A Study of Orforglipron (LY3502970) in ... The main purpose of this study, performed under Master Protocol J4M-MC-PWMP, is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/eli-lillys-oral-glp-1ra-hits-endpoints-but-trails-novos-wegovy-in-weight-loss/

Eli Lilly's oral GLP-1RA hits endpoints, but trails Novo's ... Orforglipron led to 12.4% weight loss after 72 weeks while Novo Nordisk's oral therapy showed a 13.6% drop in weight.

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15150

Orforglipron (LY3502970), a novel, oral non‐peptide glucagon ... Orforglipron treatment showed similar or enhanced HbA1c reductions and weight loss ... 13 A study of LY3502970 in participants with obesity ...

5. delta.larvol.com delta.larvol.com/Products/?ProductId=66263e96-ea3d-4d35-bc39-0de9a77ab272

orforglipron (OWL833) / Roche, Eli Lilly Lilly's oral GLP-1, orforglipron, demonstrated meaningful weight loss and cardiometabolic improvements in complete ATTAIN-1 results… (PRNewswire) - "Results ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07153471

NCT07153471 | A Study of Orforglipron (LY3502970) in ... Each study will see how well and safely orforglipron works in people with obesity or overweight who have osteoarthritis (OA) of the knee with pain.

7. investor.lilly.com investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-statistically

Lilly's oral GLP-1, orforglipron, demonstrated statistically ... Orforglipron is the first small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6% across doses.

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/551535

A Study of Orforglipron (LY3502970) in Adolescent ... Efficacy, Safety, and Pharmacokinetics of Orforglipron Once Daily Oral Versus Placebo in Adolescent Participants Who Have Obesity, or Overweight With Weight ...