Eli Lilly’s Orforglipron Hits Phase 3 Milestone: Big Weight Loss, No Injections Required

Eli Lilly’s Orforglipron Hits Phase 3 Milestone: Big Weight Loss, No Injections Required

By, Admin 8 August 2025

A pill for obesity that works like the blockbuster injectables? That’s the promise of Eli Lilly’s investigational oral GLP-1 receptor agonist, orforglipron — and the latest Phase 3 results suggest it’s the real deal.

The ATTAIN-1 Trial at a Glance

  • Size: 3,127 adults with obesity or overweight + a related health condition (no diabetes)
  • Design: 72 weeks, randomized, double-blind, placebo-controlled
  • Locations: US, Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain, Taiwan
  • Goal: Show that daily orforglipron beats placebo for weight loss

The Numbers That Matter

At the highest dose (36 mg, once daily, no food or water restrictions):

  • 12.4% average weight loss (27.3 lbs) vs 0.9% (2.2 lbs) with placebo
  • 59.6% of participants lost at least 10% of body weight
  • 39.6% lost at least 15% of body weight
  • Significant improvements in cholesterol, triglycerides, blood pressure, and inflammation (hsCRP ↓ 47.7%)

Even lower doses delivered meaningful results:

  • 6 mg: −7.5% (17.2 lbs)
  • 12 mg: −8.4% (19.0 lbs)

Safety Profile

  • Mostly mild-to-moderate GI side effects — nausea, constipation, diarrhea, vomiting, indigestion
  • No liver safety signal detected
  • Discontinuation rates due to side effects: 5–10% for orforglipron vs 2.6% for placebo

Why It’s a Big Deal

Injectable GLP-1 drugs like semaglutide (Wegovy/Ozempic) and tirzepatide (Mounjaro/Zepbound) have reshaped the weight loss market. But daily pill form changes the game:

  • No needles
  • No cold-chain logistics
  • Flexible dosing anytime of day
  • Potential for earlier intervention and long-term adherence

Eli Lilly’s Kenneth Custer, Ph.D. summed it up:

“We’re working to transform obesity care with a convenient oral therapy that supports early intervention and long-term management.”

What’s Next

  • Regulatory submission planned by year-end 2025
  • Global launch prep underway
  • More Phase 3 data coming this year, including trials in type 2 diabetes, obstructive sleep apnea, and hypertension

Bottom line: If approved, orforglipron could be the first serious oral rival to the GLP-1 injectables — and might lower the barrier for millions who want the benefits without the needle.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!