Tesamorelin · research summary

Effect of tesamorelin in people with HIV with and without dorsocervical fat: Post hoc analysis of phase III double-blind placebo-controlled trial.

Journal of clinical and translational science · 2023. Summary drawn from the study's full text. Each statement is followed by the exact sentence it comes from. This is a research summary, not medical advice.

Study type

Post hoc analysis of a phase III randomized, double-blind, multicenter clinical trial
“Here, we performed a post hoc analysis of participants receiving tesamorelin for 26 weeks in a phase III clinical trial.”

Subjects

People with HIV (PWH) with excess visceral adipose tissue (VAT), stratified by the presence or absence of dorsocervical fat
“Efficacy data were compared between individuals with and without dorsocervical fat, stratified by tesamorelin response.”

Sample size

337 participants (130 with dorsocervical fat and 207 without dorsocervical fat)
“Overall, there were 130 (39%) patients with dorsocervical fat and 207 (61%) patients without dorsocervical fat.”

Duration

26 weeks
“Participants were randomized to receive tesamorelin 2 mg or placebo daily for 26 weeks (main phase).”

Reported findings

Among tesamorelin responders, visceral adipose tissue (VAT) decreased significantly in both groups with and without dorsocervical fat, with no statistically significant difference between the groups.
“Among tesamorelin responders, VAT and waist circumference (WC) decreased in both dorsocervical fat groups and did not statistically differ (VAT P = 0.657, WC P = 0.093).”
Waist circumference decreased in both responder groups, with no statistically significant difference between those with and without dorsocervical fat.
“These reductions did not differ between groups (P = 0.093).”
In non-responder patients, VAT increased in both groups with and without dorsocervical fat, with no statistically significant difference between the groups.
“This increase in VAT from baseline did not differ between the two dorsocervical groups (P = 0.27).”

Limitations stated by the authors

The analysis excluded placebo participants and did not evaluate results at 52 weeks due to participant loss from the cross-over design; it also did not assess the impact of lipoatrophy on response.
“The current study had limitations due to the focus on VAT reduction among persons who received tesamorelin and exclusion of those who received placebo.”

Source: PubMed 36845310 · DOI 10.1017/cts.2022.515 · all study summaries

Reported findings

Among tesamorelin responders, visceral adipose tissue (VAT) decreased significantly in both groups with and without dorsocervical fat, with no statistically significant difference between the groups.

“Among tesamorelin responders, VAT and waist circumference (WC) decreased in both dorsocervical fat groups and did not statistically differ (VAT P = 0.657, WC P = 0.093).”

Waist circumference decreased in both responder groups, with no statistically significant difference between those with and without dorsocervical fat.

“These reductions did not differ between groups (P = 0.093).”

In non-responder patients, VAT increased in both groups with and without dorsocervical fat, with no statistically significant difference between the groups.

“This increase in VAT from baseline did not differ between the two dorsocervical groups (P = 0.27).”

Limitations stated by the authors

The analysis excluded placebo participants and did not evaluate results at 52 weeks due to participant loss from the cross-over design; it also did not assess the impact of lipoatrophy on response.

“The current study had limitations due to the focus on VAT reduction among persons who received tesamorelin and exclusion of those who received placebo.”