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Ascletis Pharma reveals ASC47, a promising weight loss drug, shows over 56% greater body weight reduction when combined with semaglutide in obesity treatment.
The weight loss drug showed significant signs of weight reduction 29 days into the study.
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Ascletis Pharma announced its muscle-preserving weight loss drug candidate ASC47, in combination with semaglutide, demonstrated upwards of 56.2% improved body weight reduction in participants with obesity, compared to placebo in combination with semaglutide (semaglutide monotherapy).
The ASC47-103 was a U.S.-based, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of a single-dose, ultra-long-acting subcutaneously administered ASC47 in combination with four weekly doses of 0.5 mg semaglutide. The study included 28 participants with obesity and compared a volume-matched placebo in combination with four weekly doses of 0.5 mg semaglutide.1 The study was conducted over a four-week span with a follow-up period at six weeks. The objectives of the study included the following.
ASC47 in combination with semaglutide showed no safety concerns and was well tolerated amongst participants.
On day 29 a single ultra-long-acting subcutaneous (SQ) dose of 30 mg ASC47 in combination with four weekly doses of 0.5 mg semaglutide demonstrated a 56.2% greater relative reduction in body weight compared to four weekly doses of 0.5 mg semaglutide monotherapy.1 A single SQ dose of 60 mg ASC47 in combination with four weekly doses of 0.5 mg semaglutide demonstrated a 15.1% greater relative reduction in body weight compared to four weekly doses of 0.5 mg semaglutide monotherapy.1 When analyzing results of the study participants, ASC47 in combination with semaglutide demonstrated a 31.6% greater relative reduction in body weight compared to semaglutide monotherapy.
The four weekly doses of semaglutide monotherapy demonstrated a 2.5% body weight reduction from its baseline and is consistent with the data collected from the study.1 Study results also displayed that the 10 mg dose of ASC47, in combination with semaglutide, doesn’t provide any additional decrease in body weight when compared to semaglutide monotherapy.
Additionally, Target engagement to thyroid hormone receptor beta (THRβ) in 10 mg doses of ASC47, which was measured by sex hormone binding globulin (SHBG), resulted in being measured below the threshold required for clinical effect.1 Despite the 10 mg dose not meeting the threshold for clinical effect, both the 30 mg and 60 mg doses of ASC47 demonstrated significant target engagement to THRβ. Study results also yielded data reflecting ASC47’s significant reductions in low-density lipoprotein cholesterol (LDL-C) in participants administered with the 30 mg and 60 mg doses, compared to the results of the semaglutide monotherapy group.
“As the first study to evaluate an adipose targeted THRβ agonist in combination with an incretin drug in participants with obesity, we're very encouraged that the addition of ASC47, an adipose-targeting THRβ agonist, to an incretin regimen led to a significant synergy in terms of body weight reduction, yielding up to an additional 56.2% increase in efficacy, and a substantial improvement in GI tolerability," said Jinzi Jason Wu, Ph.D., founder, chairman and CEO of Ascletis, "This study provides important proof-of-concept data that will further inform our Phase IIb combination study designs for multiple metabolic diseases such as obesity and metabolic dysfunction-associated steatohepatitis (MASH)."
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