A Randomized Placebo-Controlled Trial of HTD1801 Monotherapy in Participants With Type 2 Diabetes
Primary result · Change in HbA1c from baselineResult — go to the resultLeast squares mean difference −0.7 % 95% CI −0.8 to −0.5Authors' conclusion
HTD1801 treatment produced sustained improvements in glycemic, cardiometabolic, and inflammatory parameters
Study context
- Population
- Adults with T2D inadequately controlled with diet and exercise (≥8 weeks); HbA1c 7.0–10.5% (53–91 mmol/mol), FPG ≤13.9 mmol/Lrandomized 2:1
- Participants
- 271 vs 136
- Comparison
- HTD1801 1,000 mg BID vs placebo
- HTD1801n = 271
- Placebon = 136reference
- Primary endpoint
- Change from baseline in HbA1c
- Follow-up
- Week 24
Methodological detailsphase 3, placebo-controlled, double-blind, 28-week open-label extension
- Phase 3
- Placebo-controlled
- Double-blind
- 28-week open-label extension
Primary result
Change in HbA1c from baseline
Least squares mean difference
−0.7 %
95% CI −0.8 to −0.5
P < 0.0001
Change by group
HTD1801
−1.3
%
Placebo
−0.6
%
HTD1801vs Placebo
least squares mean difference −0.7 % (95% CI −0.8 to −0.5); P < 0.0001
As reported in the abstract
Further findings
Baseline HbA1c
- Baseline HbA1c in both groups
- 8.5% (69 mmol/mol)
Cardiometabolic and inflammatory markers · 24 weeks
- Significant improvements in key cardiometabolic and inflammatory markers with HTD1801
Durability of HbA1c reduction · 52 weeks
- HbA1c reductions were durable through 52 weeks
Safety
Mild to moderate diarrhea (most common AE)
Mild to moderate diarrhea (most common AE)
- Most diarrhea occurred at treatment initiation
Longer-term safety · 56 weeks
- Longer-term safety consistent with double-blind trial findings
Original publication
A Randomized Placebo-Controlled Trial of HTD1801 Monotherapy in Participants With Type 2 Diabetes. Diabetes Care. Published 24 August 2026. doi:10.
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