Novo Nordisk’s blockbuster diabetes drug blows the doors off in obesity, proving highly effective in driving weight loss – Endpoints News

As the obe­si­ty epi­dem­ic in Amer­i­ca wors­ened through­out the years, many biotechs cropped up hop­ing to de­vel­op weight-loss drugs that would help stem this tide. But now, No­vo Nordisk’s di­a­betes cash cow semaglu­tide is show­ing such star­tling­ly ef­fec­tive re­sults in obe­si­ty that it may have a head start in cor­ner­ing the mar­ket.

In near­ly a 2,000-per­son tri­al, par­tic­i­pants in­ject­ed them­selves with ei­ther semaglu­tide or place­bo for 68 weeks. Pa­tients in the drug arm saw an av­er­age 15% weight loss, com­pared with just 2.4% on place­bo, and al­most a third lost more than 20% of their weight. Re­searchers pub­lished the da­ta Wednes­day in the New Eng­land Jour­nal of Med­i­cine, and all p-val­ues came out to p<0.001.

Those re­sults mark a “game-chang­er” in an obe­si­ty field that, to this point, has not seen re­sults as ef­fec­tive as these, study leader Robert Kush­n­er told the New York Times.

The da­ta al­so mark an im­por­tant mile­stone in re­gards to di­a­betes. There are no ap­proved obe­si­ty med­ica­tions in the US that al­so pre­vent or treat type 2 di­a­betes. But giv­en that semaglu­tide is al­ready OK’ed in that in­di­ca­tion, the re­sults sug­gest No­vo could end up killing two birds with one stone here.

In an ex­plorato­ry end­point, clin­i­cians looked at pa­tients clas­si­fied as “pre­di­a­betes” and saw nu­mer­i­cal im­prove­ments in gly­cat­ed he­mo­glo­bin lev­els. Among those in that group, 84.1% in the semaglu­tide arm saw im­prove­ments in these lev­els, com­pared with 47.8% in the place­bo group. Re­searchers did not run a p-val­ue in this end­point.

Obe­si­ty has proved a chal­leng­ing field to treat for years, and not just with drugs. Typ­i­cal weight man­age­ment strate­gies are of­ten not enough to achieve full con­trol, and those who fol­low with bariatric surgery to al­ter the di­ges­tive tract end up re­gain­ing weight more of­ten than not.

That the­sis ap­peared to be con­firmed again in this tri­al, Kush­n­er said, as every­one in the study par­tic­i­pat­ed in a di­et and ex­er­cise pro­gram, re­gard­less of whether they re­ceived semaglu­tide.

Some con­cerns re­main over the drug’s safe­ty, per a NE­JM ed­i­to­r­i­al pub­lished along­side the da­ta. Though sim­i­lar lev­els of side ef­fects were seen in both groups, 89.7% in the drug arm and 86.4% in con­trol, there was a high­er rate of gas­troin­testi­nal events among those tak­ing semaglu­tide — 74.2% vs. 47.9%.

Most of these fell in­to the mild or mod­er­ate cat­e­gories, but se­ri­ous gas­troin­testi­nal dis­or­ders ac­count­ed for the dif­fer­ence in to­tal se­vere ad­verse event rates, the study au­thors said. Se­ri­ous ad­verse events were re­port­ed in 9.8% and 6.4% of semaglu­tide and place­bo par­tic­i­pants, re­spec­tive­ly, with 1.4% of par­tic­i­pants on semaglu­tide re­port­ing a se­vere GI event and 0% in the place­bo group.

The tri­al pop­u­la­tion al­so did not prove rep­re­sen­ta­tive of the US pop­u­la­tion as a whole, with most par­tic­i­pants be­ing women (74.1%) and White (75.1%). Over­all, how­ev­er, the re­sults proved to be a sig­nif­i­cant step in the right di­rec­tion, the au­thor wrote.

The GLP-1 drug has al­ready reaped bil­lions for No­vo Nordisk, tak­ing in $1.64 bil­lion in 2019 and $1.5 bil­lion in the first half of 2020. In ad­di­tion to di­a­betes, the com­pa­ny al­so has re­ceived break­through ther­a­py des­ig­na­tion for semaglu­tide in NASH, an­oth­er area filled with speed bumps.