Safety, pharmacokinetics and pharmacodynamics of multiple‐dose noiiglutide (SHR20004), a novel GLP ‐1 receptor agonist, in Chinese obese subjects without diabetes mellitus

Dec 2, 2024Diabetes, obesity & metabolism

Safety and body response to repeated doses of noiiglutide, a new GLP-1 drug, in obese Chinese adults without diabetes

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Abstract

Participants receiving the highest dose of noiiglutide lost an average of 7.46 kg over the treatment period.

Most adverse events related to treatment were mild to moderate, with no serious adverse events reported.
Blood levels of noiiglutide stabilized after 4 days of daily injections, showing no significant accumulation.
The average elimination half-life of noiiglutide was between 9.90 and 11.8 hours at steady state.
Weight loss and reductions in BMI were greater in all noiiglutide groups compared to the placebo group.
Weight loss increased with longer treatment duration across the noiiglutide dosage groups.

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AIMS: This study aimed to assess the safety, pharmacokinetics and pharmacodynamics of noiiglutide (SHR20004), a novel glucagon-like peptide-1 receptor agonist, in Chinese obese participants without diabetes mellitus (DM).

MATERIALS AND METHODS: This phase 1, randomised, double-blind, placebo-controlled study enrolled adult participants with body mass index (BMI) ≥28 kg/m. The study used a titration method, each subject received daily noiiglutide injection for 3-6 weeks, until reaching the final dose of 0.18, 0.24, 0.30 or 0.36 mg per day. Each dose group consisted of 10 participants, with eight receiving noiiglutide and two receiving placebos. Safety assessments were conducted throughout the study, and pharmacokinetics and pharmacodynamics were evaluated. 2

RESULTS: Most treatment-emergent adverse events were of mild to moderate in severity, with no serious adverse event or adverse event led to withdraw. Blood concentration of noiiglutide reached a steady state after daily administration for 4 days, with no significant accumulation. Mean elimination half-life (t) was between 9.90 and 11.8 h at steady state. At the end of treatment, the mean weight loss compared to baseline for the placebo group and each treatment group was -1.89, -3.26, -5.45, -4.35 and -7.46 kg respectively. The weight and BMI reductions observed in each noiiglutide treatment group were greater than those in the placebo group and exhibited an increasing trend with extended administration duration. 1/2

CONCLUSIONS: Daily administration of noiiglutide using a titration method was well tolerated by Chinese obese participants without DM and showed potential therapeutic effect for weight loss.

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Safety, pharmacokinetics and pharmacodynamics of multiple‐dose noiiglutide (SHR20004), a novel GLP ‐1 receptor agonist, in Chinese obese subjects without diabetes mellitus

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