In September 2025, Roche advanced CT-388 into Phase III clinical development, marking a significant milestone in its strategy to compete with established incretin leaders such as Eli Lilly and Novo Nordisk in what analysts estimate could become a USD 150 billion annual market by the early 2030s.
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CT-388 Drug Overview
CT-388 is a once-weekly subcutaneous injectable dual GLP-1/GIP receptor agonist designed for the treatment of obesity and type 2 diabetes mellitus (T2D).
The molecule was engineered with a distinctive biased signaling mechanism, demonstrating potent GLP-1 and GIP receptor activity with minimal β-arrestin recruitment. This design aims to reduce receptor desensitization, prolong pharmacologic activity, enhance durability of effect, and potentially improve tolerability compared to traditional incretin therapies.
CT-388 is currently in Phase II development for obesity (NCT06525935) and type 2 diabetes mellitus (NCT06628362).
Discover how CT-388 compares to leading GLP-1/GIP therapies from Eli Lilly and Novo Nordisk across efficacy, safety, pricing, and market positioning @ https://www.delveinsight.com/sample-request/ct-388-market-forecast
Key Factors Driving CT-388 Growth
1. Market Share Gains and Anticipated Patient Starts
CT-388 remains in clinical development and has not yet achieved commercial market share. However, early Phase Ib data suggest strong commercial potential upon approval.
In May 2024, Genentech announced positive results from a 24-week Phase Ib trial in adults with obesity:
- 18.8% mean placebo-adjusted weight loss (p < 0.001)
- 100% achieved >5% weight loss
- 85% achieved >10% weight loss
- 70% achieved >15% weight loss
- 45% achieved >20% weight loss
These results are clinically meaningful and compare favorably to other injectable GLP-1 or GLP-1/GIP therapies at similar time points.
Anticipated new patient starts will depend on Phase II/III readouts and regulatory approvals. If efficacy and safety are maintained in larger populations and longer-duration trials, CT-388 could see rapid prescriber uptake.
Roche is simultaneously scaling its obesity and metabolic portfolio following its Carmot Therapeutics acquisition, reinforcing long-term commercialization capabilities.
2. Expansion Across Key Indications
Obesity / Overweight (Primary Focus) CT-388 has demonstrated substantial weight loss in obese adult populations and is advancing into larger Phase II/III trials.
Type 2 Diabetes Mellitus (T2D) Additional study arms are evaluating CT-388 in patients with obesity and T2D. Early data indicate improvements in glucose homeostasis and normalization of glycemia in pre-diabetes subgroups.
In Phase Ib, all treated participants with baseline pre-diabetes achieved glycemic normalization at Week 24 — an encouraging signal for metabolic disease prevention.
Comorbid Cardiometabolic Risk Populations Ongoing studies include participants with pre-diabetes, hypertension, and dyslipidemia to assess whether CT-388 improves broader metabolic risk markers.
Future Phase IIb and Phase III studies are expected to evaluate higher doses and longer treatment durations (72+ weeks), further clarifying durability, cardiometabolic impact, and safety profile.
Discover how CT-388 compares to leading GLP-1/GIP therapies from Eli Lilly and Novo Nordisk across efficacy, safety, pricing, and market positioning @ https://www.delveinsight.com/report-store/ct-388-market-forecast
3. Geographic Expansion Strategy
CT-388 is being developed globally, with trials likely spanning North America, Europe, and other key regions.
Following potential approvals, emerging markets such as Asia-Pacific and Latin America are expected to represent significant long-term growth opportunities, contingent on pricing and reimbursement alignment.
Roche is scaling manufacturing capacity and expanding its metabolic disease infrastructure to support global commercialization.
Regulatory Status and Expectations
As of mid-2024:
- Positive Phase Ib data completed
- Phase II / IIb trials underway
- Phase III trial initiated in 2025
- No regulatory approvals yet
Expected initial filings will likely target obesity first, followed by potential expansion into T2D and cardiometabolic risk populations.
If approved in both obesity and diabetes, CT-388 would meaningfully diversify Roche’s metabolic portfolio and establish a competitive presence in the incretin class.
Strong Volume Momentum Driven by Clinical Performance
The 24-week Phase Ib results highlight compelling weight-loss efficacy.
Tolerability appears consistent with the incretin class, with primarily mild-to-moderate gastrointestinal side effects and no unexpected safety signals to date.
This supports potential long-term adherence and real-world adoption, pending confirmation in larger datasets.
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Competitive Differentiation and Market Trends
Dual GLP-1/GIP Agonism + Biased Signaling
CT-388 differentiates itself via dual receptor targeting combined with minimized β-arrestin recruitment.
This may reduce receptor internalization and improve durability versus conventional incretin therapies.
Efficacy Positioning
The 18.8% placebo-adjusted weight loss over 24 weeks positions CT-388 competitively within the obesity treatment landscape.
If sustained or improved in longer trials, CT-388 could achieve best-in-class status.
Safety and Tolerability
GI-related adverse events were mostly mild to moderate, consistent with the incretin class.
No major safety signals emerged in early studies.
Market Tailwinds Supporting CT-388
- Growing global obesity prevalence
- Increasing payer focus on metabolic disease prevention
- Rising demand for durable weight-loss therapies
- Expansion of cardiometabolic risk treatment strategies
- Emphasis on real-world evidence and long-term safety
Risks and Headwinds
- Need for long-term safety validation (72+ weeks)
- Pricing and reimbursement pressures
- Strong competition from established brands
- Manufacturing and supply chain scalability
- Injectable route may limit access in some regions
Request free sample report for ongoing updates on CT-388 clinical milestones, regulatory developments, and emerging competition in the incretin landscape @ https://www.delveinsight.com/sample-request/ct-388-market-forecast
CT-388 Market Report Overview
The “CT-388 Sales Forecast and Market Size Analysis – 2034” report provides detailed insights across the 7MM:
- United States
- Germany
- France
- Italy
- Spain
- United Kingdom
- Japan
The report covers:
- Mechanism of Action (MoA)
- Dosage and administration
- Clinical development timeline
- Regulatory milestones
- Sales forecasts through 2034
- SWOT analysis
- Competitive intelligence
- Pricing and reimbursement insights
- Peak sales projections
- Pipeline competitor landscape
Analytical Perspective
DelveInsight’s assessment evaluates CT-388’s positioning relative to other emerging and marketed obesity/T2D therapies, analyzing strengths, weaknesses, commercial potential, and anticipated uptake.
The forecast incorporates:
- Clinical data interpretation
- Market access assumptions
- Competitive landscape modeling
- Regional reimbursement dynamics
- Patent and generic entry considerations
Outlook Through 2034
The CT-388 market scenario is expected to evolve significantly over the next decade.
Strong clinical efficacy, differentiated receptor signaling, expansion into T2D and cardiometabolic populations, and Roche’s global commercialization strategy position CT-388 as a potentially disruptive entrant in the metabolic disease landscape.
If Phase III trials confirm early findings, CT-388 could emerge as a major contender in the global obesity and diabetes therapeutics market.
About DelveInsight
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