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CT-388: Research & Studies

Scientific evidence, clinical trials, and research findings

Evidence Level: moderate
✓Reviewed byDr. Research Team(MD (composite credential representing medical review team), PhD in Pharmacology)
📅Updated February 12, 2026
Verified

📌TL;DR

  • •2 clinical studies cited
  • •Overall evidence level: moderate
  • •8 research gaps identified
Evidence pyramid for CT-388 research
Overview of evidence quality and study types

Research Studies

Effects of CT-388, a once-weekly signaling-biased dual GLP-1/GIP receptor agonist, on weight loss and glycemic control in preclinical models and participants with obesity

Roche/Genentech/Carmot Therapeutics investigators (2025) • Cell Metabolism

PubMed

Comprehensive publication characterizing CT-388 as a unimolecular peptide-based cAMP signal-biased dual GLP-1R/GIPR agonist. Includes preclinical data and Phase 1 clinical results.

Key Findings

  • CT-388 is cAMP signal-biased with minimal beta-arrestin recruitment at both GLP-1R and GIPR
  • Improved glycemic control in mice and monkeys
  • Reduced body weight and suppressed appetite in mice
  • Improved MASH pathology in mouse models
  • Phase 1b: 18.8% placebo-adjusted weight loss at 24 weeks
  • 100% of CT-388 treated participants achieved 5%+ weight loss in Phase 1b
  • Well tolerated with safety profile consistent with incretin class

Limitations: Phase 1 study with relatively small sample sizePreclinical data may not fully translate to humansLong-term safety data not available

Phase 2 Trial of CT-388 in Adults with Obesity

Roche/Genentech investigators (2026) • Roche press release / conference presentation

Phase 2 randomized, placebo-controlled trial of three subcutaneous CT-388 dose levels in 469 adults with obesity or overweight over 48 weeks.

Key Findings

  • 22.5% placebo-adjusted weight loss at 24 mg dose at 48 weeks
  • 96% achieved 5%+ weight loss at highest dose
  • 87% achieved 10%+ weight loss
  • 48% achieved 20%+ weight loss
  • 26% achieved 30%+ weight loss
  • 54% reduced BMI below obesity threshold (30 kg/m2) vs 13% placebo
  • No weight loss plateau observed at 48 weeks
  • GI adverse events were mild to moderate and consistent with incretin class
  • Discontinuation due to AEs: 5.9% (CT-388) vs 1.3% (placebo)

Limitations: Full peer-reviewed publication pendingSingle Phase 2 trialNo active comparator armNo cardiovascular outcomes data

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Research timeline for CT-388
Key studies and discoveries over time

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🔍Research Gaps & Future Directions

  • •Phase 3 data not yet available (planned Q1 2026)
  • •No head-to-head comparisons with tirzepatide or semaglutide
  • •Cardiovascular outcomes data not available
  • •Long-term safety beyond 48 weeks not characterized
  • •Whether biased signaling translates to superior long-term outcomes is unknown
  • •Exact molecular structure not publicly disclosed
  • •Effects on type 2 diabetes glycemic endpoints in dedicated trials
  • •Weight maintenance after treatment discontinuation

Research Overview#

CT-388 has been characterized through preclinical studies, a Phase 1b dose-finding trial, and a Phase 2 efficacy trial. The key publication in Cell Metabolism (PMID 41319798) established CT-388 as a signal-biased dual GLP-1/GIP agonist with minimal beta-arrestin recruitment. Phase 2 results showed 22.5% placebo-adjusted weight loss at 48 weeks, positioning CT-388 among the most effective anti-obesity therapies in development.

Cell Metabolism Publication (Phase 1b + Preclinical)#

The comprehensive Cell Metabolism publication characterized CT-388 across preclinical and clinical settings:

Preclinical Findings#

  • Confirmed cAMP signal-biased agonism at both GLP-1R and GIPR
  • Minimal beta-arrestin recruitment at both receptors
  • Improved glycemic control in diabetic mouse and monkey models
  • Significant body weight reduction and appetite suppression in mice
  • Improved metabolic dysfunction-associated steatohepatitis (MASH) pathology in mouse models

Phase 1b Clinical Results (24 Weeks)#

The Phase 1b trial was a double-blind, randomized, placebo-controlled, multiple ascending dose study in adults with obesity:

  • Primary endpoint: 18.8% placebo-adjusted weight loss at 24 weeks
  • Responder analysis:
    • 100% achieved at least 5% weight loss
    • 85% achieved at least 10% weight loss
    • 70% achieved at least 15% weight loss
    • 45% achieved at least 20% weight loss
  • Safety: Well tolerated; all TEAEs mild to moderate; no serious AEs, no discontinuations due to AEs

Phase 2 Clinical Trial (48 Weeks)#

The Phase 2 trial enrolled 469 adults with obesity or overweight and randomized them to three subcutaneous CT-388 dose levels or placebo for 48 weeks.

Key Efficacy Results (24 mg Dose)#

  • Weight loss: 22.5% placebo-adjusted mean weight loss at 48 weeks
  • Responder thresholds:
    • 96% achieved at least 5% weight loss
    • 87% achieved at least 10% weight loss
    • 48% achieved at least 20% weight loss
    • 26% achieved at least 30% weight loss
  • BMI reduction: 54% reduced BMI below 30 kg/m2 (obesity threshold) versus 13% placebo
  • No plateau: Weight loss was progressive at 48 weeks with no evidence of plateau

Safety Profile#

  • GI adverse events were the most common (consistent with incretin class)
  • Most GI events were mild to moderate
  • Discontinuation due to AEs: 5.9% (CT-388) versus 1.3% (placebo)
  • No serious safety signals reported

Evidence Quality Assessment#

The evidence base for CT-388 is moderate:

Strengths:

  • Published in Cell Metabolism (high-impact journal) with preclinical and Phase 1 data
  • Large Phase 2 trial (469 patients, 48 weeks)
  • Consistent dose-response relationship
  • Novel mechanism (signal-biased) with strong preclinical rationale
  • Low discontinuation rates

Limitations:

  • No peer-reviewed Phase 2 publication yet
  • No active comparator arm in Phase 2
  • Phase 3 not yet initiated
  • No head-to-head data versus tirzepatide or semaglutide
  • No cardiovascular outcomes data

MASH/Liver Data#

Preclinical data showed improvement in MASH pathology. CT-388's effect on liver-related MRI parameters in patients with obesity has been presented at the ADA (Abstract 125-OR), suggesting potential benefits for liver steatosis.

Research Gaps#

  1. Phase 3 trials: Planned for Q1 2026 but not yet initiated
  2. Long-term outcomes: Whether biased signaling produces superior sustained outcomes
  3. Head-to-head comparisons: No trials versus tirzepatide or semaglutide
  4. Cardiovascular outcomes: No CVOT data
  5. Diabetes endpoints: Dedicated T2D trials not yet reported
  6. Weight maintenance: Durability after discontinuation unknown
  7. MASH indication: Further clinical data needed for liver disease

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