GLP-1 Clinical Practice Updates: August 2025 Key Developments
August 2025 delivered significant clinical practice updates that advance the GLP-1 treatment landscape, including the first generic approval, expanded FDA indications, and major oral therapy breakthroughs. These evidence-based updates provide actionable insights every provider should integrate into their practice.
In this GLP-1 round up:
- First generic GLP-1 for weight loss approved, dramatically reducing patient costs FDA expands
- Wegovy indication to liver disease, opening new patient populations
- Oral GLP-1 therapies show injectable-level efficacy with regulatory submissions starting Enhanced
- FDA safety monitoring reveals 1,000+ adverse events from compounded products
Table of Contents
First Generic GLP-1 Approved for Weight Loss
The FDA approved Teva Pharmaceuticals’ generic version of Saxenda® (liraglutide injection), marking the first-ever generic GLP-1 specifically indicated for weight loss. This approval represents a significant shift in the GLP-1 market accessibility landscape.
- Market Impact
Saxenda® had annual sales of $165 million as of June 2025, and the generic approval is expected to substantially reduce costs for patients and healthcare systems. The generic liraglutide injection is indicated for:
- Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity
- Adults with overweight in the presence of at least one weight-related comorbid condition
- What This Means for Your Practice
- Improved patient access: Generic pricing may make GLP-1 therapy accessible to previously cost-prohibited patients
- Insurance coverage: Payers may be more willing to cover generic options, potentially reducing prior authorization barriers
- Treatment continuity: Provides an alternative when brand-name products face supply constraints
- Patient counseling: Opportunity to discuss cost-effective treatment options with appropriate candidates
Action Items: Review your current liraglutide prescribing patterns and consider how generic availability might expand your patient population. Update prior authorization processes to include generic options.
FDA Expands Wegovy® Indication to Liver Disease (MASH)
Expanding Beyond Weight Loss
Wegovy® (semaglutide) has received FDA approval to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis, marking the first GLP-1 therapy approved for serious liver disease. This approval affects approximately 6% of U.S. adults (14.9 million people) who have MASH.
- Clinical Evidence
- 63% of participants receiving Wegovy had MASH resolution and no worsening of liver scarring compared to 34% with placebo
- 37% of participants on Wegovy had improvement in liver scarring and no worsening of MASH, compared to 22% with placebo
- What This Means for Your Practice:
This approval significantly expands the clinical utility of GLP-1 therapy beyond traditional obesity and diabetes indications. MASH is a progressive disease that can lead to cirrhosis, liver cancer, and death, making this a critical therapeutic advance.
- Expanded patient population: Consider GLP-1 therapy for patients with MASH and moderate-to-advanced fibrosis
- Multidisciplinary care: Opportunity for collaboration with hepatologists and gastroenterologists
- Comprehensive screening: Evaluate obesity patients for potential liver involvement
- Insurance coverage: New indication may improve coverage for patients with liver disease
Action Items: Review current patient population for potential MASH candidates. Consider liver function screening protocols for obesity patients. Update treatment algorithms to include liver disease considerations.
PIPELINE: Oral GLP-1 Therapies Show Major Progress
Eli Lilly's Orforglipron Advances
Eli Lilly announced successful completion of their third Phase 3 trial for orforglipron, their oral GLP-1 medication, triggering global regulatory submissions this year. The ATTAIN-2 trial demonstrated compelling results in a challenging population—patients with obesity or overweight and type 2 diabetes.
- Key Results:
- 22.9 lbs (10.5%) average weight loss on the highest dose (36 mg) at 72 weeks
- A1C reduced by 1.8% from baseline of 8.1%
- 75% of participants achieved A1C ≤6.5% (at or below diabetes threshold)
- 50.1% achieved ≥10% weight loss vs. 7.0% with placebo
Viking Therapeutics' VK2735 Oral Results
Viking Therapeutics announced positive Phase 2 results for their oral VK2735 tablet, showing up to 12.2% (26.6 lbs) mean weight loss after just 13 weeks of treatment.
- Key Results
- Progressive weight loss with no plateau observed at 13 weeks
- 97% of subjects achieved ≥5% weight loss vs. 10% for placebo
- 80% of subjects achieved ≥10% weight loss vs. 5% for placebo
- 99% of GI-related adverse events were mild or moderate
- What This Means for Your Practice:
- Future treatment options: Oral formulations may improve patient acceptance and adherence
- Simplified protocols: No injection training or storage requirements
- Expanded access: Oral options may appeal to injection-averse patients
- Timeline planning: Orforglipron regulatory submissions beginning this year suggest potential approval in 2026-2027
Action Items: Begin patient education about upcoming oral options. Consider patient preferences for injection vs. oral therapy in treatment planning. Prepare practice workflows for oral GLP-1 management.
Enhanced Safety Monitoring and Enforcement
Updated FDA Safety Data
The FDA updated their safety monitoring data through July 31, 2025, reporting:
- 605 adverse events associated with compounded semaglutide (up from 520 in April)
- 545 adverse events associated with compounded tirzepatide (up from 480 in April)
FDA "Green List" Initiative
In early September 2025, the FDA created a “green list” of approved active pharmaceutical ingredients in GLP-1 drugs to keep unverified ingredients out of the U.S. supply chain. This initiative aims to help providers and patients identify legitimate medication sources.
- What This Means for Your Practice: •
- Enhanced vigilance: Continued need for medication source verification
- Patient education: Ongoing counseling about risks of compounded/counterfeit products
- Documentation: Maintain robust adverse event reporting protocols
- Resource utilization: Use FDA green list as reference for legitimate ingredients
Action Items: Review current medication verification protocols. Update patient education materials about compounded drug risks. Ensure staff training on adverse event recognition and reporting.
Key Takeaways for Providers
- Immediate Opportunities (Next 30 Days)
- Assess generic liraglutide impact on current patient population and cost barriers
- Review MASH screening protocols for obesity patients
- Update patient education materials about oral GLP-1 developments
- Strategic Planning (Next 90 Days)
- Prepare for oral GLP-1 availability by evaluating patient preferences and workflow implications
- Enhance safety monitoring protocols based on updated FDA guidance
Conclusion
August’s developments continue the transformative trends reshaping GLP-1 therapy in 2025. The generic approval breakthrough addresses ongoing insurance coverage challenges and patient access barriers, while oral GLP-1 advances represent the next evolution beyond current pipeline innovations.
The convergence of cost reduction through generics, expanded therapeutic applications via the MASH indication, and the promise of oral formulations positions late 2025 as a pivotal moment for GLP-1 therapy accessibility and clinical utility. For providers, these developments demand both immediate protocol adjustments and strategic planning for the oral therapy era ahead.
Enhanced regulatory enforcement and safety monitoring requirements make verified sourcing and adverse event protocols more critical than ever for practice protection and patient safety.
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