42 A phase 3 trial including adults with T2DM receiving orforglipron daily (3 mg, 12 mg or 36 mg) showed significant placebo-adjusted reductions in HbA 1c (1.07%) and weight loss (5.9%) at the highest dose
R 2 is selected from the group consisting of: hydrogen, -CH(R a )OPO(OH)2, -CO-Y, -t-PO(OY) 2 , +PO(OH) 2 , -C(=0)-Y, -CO-U, -C(=0)-(CH 2 )rU, and -CH2-V, where R a is hydrogen or CH3, where Y is -Z-(CH2)q-W-R b , q is 0-4, where Z and W are independently selected from the group consisting of: CH2, O, S, R C and R b , where R c is selected from the group consisting of: hydrogen, C1-C4 alkyl, and C3-C6 cycloalkyl, R b is selected from the group consisting of: hydrogen, C1-C12 alkyl, C1-C12 substituted alkyl, C1-C12 alkenyl, C1-C12 substituted alkenyl, C1-C12 alkynyl, C1-C12 substituted alkynyl, C3-C8 cycloalkyl, C3-C8 substituted cycloalkyl, C6-C10 aryl, C6-C10 substituted aryl, C3-C8 heterocycloalkyl, C3-C8 substituted heterocycloalkyl, C4-C10 heteroaryl, and C4-C10 substituted heteroaryl, where r is 0-5, U is selected from aryl, heteroaryl or heterocycloalkyl, where V is -0-C(=0)-Q-(CH2)r-R d , where Q is selected from the group consisting of: a bond, O, and N(R C ), where R d is selected from the group consisting of: C6-C10 aryl, C4-C10 heteroaryl, C3-C8 heterocycloalkyl, a hexose, a pentose, and - (5-methyl-2-oxo-l,3-dioxol-4-yl)methyl), or alternatively -C(=0)-Y forms an amide bond thru a nitrogen atom on Y in which case Y is a selected from the group consisting of: glycine, sarcosine, ,-diemthyl glycine, alanine, valine, leucine, isoleucine, lysine, ornithine, arigine, serine, and theronine
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The agency would have to solicit public comment and an advisory committee of health and pharmacy experts would have to review the FDAs research
