Syntis Bio has reported results from the multiple ascending dose (MAD) segment of its Phase I/Ib SYNTIETY-1 trial of SYNT-101, an oral therapy for the potential obesity treatment.
The 28-day study, involving 23 overweight or obese adults, evaluated changes in metabolic markers and weight loss outcomes across three dose groups ranging from 857mg to 2,571mg.
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SYNT-101 was tolerated at all dose levels, with no participant withdrawals or dose reductions. Gastrointestinal adverse events occurred at rates similar to those seen in individuals receiving a placebo.
Exploratory pharmacodynamic measures indicated that participants who were given SYNT-101 showed two to five-fold rises in satiety hormones glucagon-like peptide-1 (GLP-1) and peptide YY (PYY), and reduced levels of the “hunger hormone” ghrelin.
The hormone changes were said to be comparable to those observed after gastric bypass surgery.
SYNT-101 recipients lost more weight than placebo participants in all three groups, with weight loss described as similar to that seen with GLP-1 therapies over a comparable period.
Syntis Bio chief development officer David Rosenbaum said: “SYNT-101 was designed to produce a specific multi-hormone signature, one that mimics the metabolic response of bariatric surgery but via a once-daily oral tablet.”
“The continued demonstration of tolerability across all dose cohorts, together with encouraging efficacy signals, reinforce the potential of a therapy that, unlike GLP-1s and other obesity drug candidates, is specifically designed to avoid systemic circulation.
“Overall, these data mark a significant de-risking milestone for SYNT-101 and provide a strong foundation for its advancement into Phase II.”
The MAD findings extend earlier results from the single ascending dose arm of the trial reported in July 2026.
The company also noted that SYNT-101 is intended to act locally in the gut, forming a temporary lining in the duodenum and prompting satiety responses when food is consumed.
In March 2026, Syntis Bio dosed the first patient in the SYNTIETY-1 Phase I/Ib trial of SYNT-101, its investigational once-daily oral pill, targeting obesity.
