Caliway Files US IND for Phase 2 Study Combining CBL-514 With Tirzepatide in Obesity

Caliway Files US IND for Phase 2 Study Combining CBL-514 With Tirzepatide in Obesity

By, Admin 26 December 2025

Caliway Biopharmaceuticals has taken a decisive step into the next phase of weight management innovation.

The company has completed submission of an Investigational New Drug (IND) application to the US FDA for a Phase 2 clinical trial of CBL-514 for weight management.

The study will evaluate CBL-514 in combination with Zepbound® (tirzepatide), Eli Lilly’s dual GLP-1/GIP receptor agonist.

What the Phase 2 Study Will Evaluate?

The trial, named CBL-0201WR, is a randomized, placebo-controlled, multi-center Phase 2 study to be conducted in the United States.

Key study details include:

  • Approximately 120 adults with obesity or overweight plus comorbidities
  • Combination treatment of tirzepatide followed by CBL-514
  • Long-term follow-up after treatment discontinuation

The focus is not just weight loss, but what happens after treatment stops.

Key Endpoints: Fat, Weight, and Body Composition

Unlike many obesity trials, this study goes deeper than the scale.

Primary and secondary endpoints include:

  • Changes in abdominal subcutaneous fat volume measured by MRI
  • Changes in body weight
  • Detailed body composition analysis using DEXA

DEXA assessments will track:

  • Total body fat percentage
  • Visceral fat
  • Muscle mass

All MRI and DEXA data will be analyzed independently to reduce bias.

Why This Combination Matters?

GLP-1 therapies have transformed weight loss, but they come with limitations.

Clinical evidence shows that GLP-1 drugs:

  • Shrink fat cells rather than reduce fat cell number
  • Often lead to weight regain after discontinuation
  • May worsen body composition post-treatment

CBL-514 is designed to address these gaps.

How CBL-514 Works Differently?

CBL-514 uses a fundamentally different mechanism. According to completed studies, it:

  • Induces selective adipocyte apoptosis
  • Inhibits new fat cell formation
  • Promotes fat metabolism

This makes it a potential mechanistic complement to appetite-suppressing GLP-1 therapies.

Study Design Focuses on Long-Term Outcomes

In the trial design:

  • Participants receive tirzepatide alone for eight weeks
  • CBL-514 is then added for six combination administrations
  • Both treatments are discontinued
  • Patients enter a structured long-term follow-up

The goal is simple but ambitious: sustained fat reduction without rebound.

Strong Preclinical and Clinical Foundation

CBL-514 is not an early-stage concept.

To date:

  • 10 clinical trials completed
  • 544 subjects enrolled
  • All efficacy and safety endpoints met

Animal studies also show improved fat composition and better weight maintenance after GLP-1 withdrawal.

Market Context: Why Timing Matters?

The weight management market is exploding.

  • Tirzepatide sales reached $24.8 billion in the first three quarters of 2025
  • Global weight-loss drug market could reach $150 billion by 2035
  • CAGR estimated at ~25%

The next wave is not bigger weight loss. It is better weight loss.

The Bigger Picture

Caliway’s Phase 2 IND marks a shift in obesity drug development. The industry focus is moving toward:

  • Fat quality over weight quantity
  • Post-treatment durability
  • Body composition preservation

CBL-514 is positioned directly at that intersection.

If successful, this approach could redefine what “effective weight management” really means.

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!