Nuforme Research Team · · 6 min read
Searching tesamorelin canada can produce a confusing mix of old drug records, current catalogue listings, and broad claims about abdominal fat. The central distinction is straightforward but important: Health Canada issued Egrifta, a tesamorelin prescription drug, a Notice of Compliance in 2014. The current Drug Product Database, however, lists its 2 mg DIN as Cancelled Pre-Market and its 1 mg DIN as Cancelled Post-Market, effective September 30, 2022.
That history does not tell us that a Canadian prescription product is currently marketed. It also does not turn tesamorelin’s clinical-trial results into evidence for ordinary midlife weight management. The human evidence is real, but it comes mainly from adults living with HIV and HIV-associated abdominal fat accumulation.
Research Confidence
★★★★☆ The evidence is based on several randomized, placebo-controlled human trials, including two phase 3 trials pooled across 806 participants. They used CT scans to measure internal abdominal fat over 26 weeks. Confidence drops sharply when the question shifts to menopause, healthy aging, or general weight management, which these trials did not test.
Study Snapshot
- Study type: pooled analysis of two multicentre, randomized, double-blind, placebo-controlled phase 3 trials
- Participants: 806 adults receiving antiretroviral therapy for HIV with excess abdominal fat, about 15% women
- Duration: 26 weeks, with an additional 26-week blinded extension for eligible participants
- Measured: percentage change in CT-measured visceral adipose tissue, meaning fat stored around internal abdominal organs
- Found: placebo-adjusted visceral-fat change was -15.4% at week 26; body-mass index did not differ significantly between groups
- Funding: Theratechnologies affiliations and company-associated authors were reported
Why This Matters: Tesamorelin Canada Is Not a Simple Availability Search
For someone noticing more abdominal weight in midlife, a scan-based reduction in deep abdominal fat can sound like an answer to a familiar frustration. But visceral fat and body weight are not interchangeable. A CT scan can show a change in fat around organs even when the scale and body-mass index, or BMI, barely move.
That distinction matters because the leading tesamorelin trials were built around a specific HIV-related body-composition problem, not the gradual changes around perimenopause, menopause, aging, or a busy decade of life. The trials provide a useful example of why weight-management research needs careful reading: what was measured determines what a result can mean.
The Canadian Record: An Authorization Is Not Proof of Current Marketing
Health Canada issued Egrifta a Notice of Compliance on April 29, 2014. A Notice of Compliance is Health Canada’s authorization for a prescription drug to be marketed after its review. That is a historical regulatory fact, not a standing statement about present availability.
Current Drug Product Database entries list Egrifta 2 mg per vial, DIN 02423677, as Cancelled Pre-Market, and Egrifta 1 mg per vial, DIN 02438712, as Cancelled Post-Market. The latter cancellation took effect September 30, 2022. A DIN is a Drug Identification Number assigned to an authorized drug product; a cancelled DIN should not be read as confirmation that the product remains marketed in Canada.
The regulatory records reviewed here also do not establish whether tesamorelin could be compounded in Canada or whether any particular research-use supply has a Canadian legal pathway. Those are separate questions, and they cannot be answered from an old authorization alone.
The Core Trials: Internal Abdominal Fat, Not General Weight Loss
The largest evidence base comes from randomized, double-blind, placebo-controlled trials in people with HIV receiving antiretroviral therapy and living with excess abdominal fat. Randomized means participants were assigned by chance; double-blind means neither participants nor investigators knew who received tesamorelin or placebo during the blinded phase.
In the pooled phase 3 analysis, 806 participants received tesamorelin 2 mg by subcutaneous injection once daily or an identical placebo for 26 weeks. CT imaging estimated visceral adipose tissue. At week 26, the placebo-adjusted change was -15.4%. BMI did not differ significantly between groups. In plain terms, the programme recorded less deep abdominal fat on scans without demonstrating a meaningful difference in BMI.
An earlier 26-week randomized trial of 412 participants reported a 15.2% reduction in visceral fat with tesamorelin, compared with a 5.0% increase with placebo. Overall discontinuation was 20.5%, with no statistically significant difference in discontinuation between groups. That is a substantial number of people who did not complete the trial, even though it was not higher in one group than the other.
A Narrower Question: Liver-Fat Measurements in HIV Studies
The same clinical setting also prompted researchers to examine liver fat. In a 50-person randomized, double-blind, placebo-controlled trial lasting six months, the difference in visceral-fat change between groups was -42 cm². MRI-based liver-fat measurement also fell more in the tesamorelin group. Fasting glucose rose temporarily at two weeks in the tesamorelin group, while the difference between groups at six months was not statistically significant.
A separate 12-month randomized, double-blind, placebo-controlled trial enrolled 61 people with HIV and MRI-defined fatty liver. The estimated between-group difference in liver-fat change was -4.1 percentage points. Glucose measures did not differ between groups at 12 months, while local injection-site complaints were more common with tesamorelin.
These were meaningful, carefully measured outcomes in selected participants. They do not answer whether tesamorelin changes the course of fatty liver, reduces clinical events, or produces the same scan findings in people without HIV.
What This Means For You: A Scan Result Is Not a Midlife Weight-Loss Promise
If your real question is whether something could shift the abdominal changes of midlife, the honest answer is that these trials do not establish it. They were not designed for menopause-related body-composition changes, and they did not make scale weight their central outcome.
A useful conversation with a clinician can separate concerns that are often bundled together: waist size, overall weight, blood sugar, liver-fat risk, medication effects, sleep, and changes in muscle mass. They are related, but they are not one problem with one measurement.
It is also worth understanding how a trial measured its result before attaching personal meaning to it. Our guide to understanding research peptides explains why trial population, comparator, and endpoint matter as much as the headline finding.
What This Tells Us About Women Specifically: Tesamorelin Canada Evidence Has a Major Menopause Gap
Women accounted for about 15% of participants in the pooled 806-person phase 3 analysis. The investigators reported that the direction and size of visceral-fat change appeared similar in female and male subgroups, but the female subgroup was small.
Menopausal status was not reported. Neither was hormone-therapy use, and the major trials did not report outcomes designed around perimenopausal or postmenopausal body-composition change. That missing context matters: hormonal transition can affect where fat is stored, muscle mass, sleep, and metabolic markers. The available data cannot tell a midlife woman whether the HIV-study result applies to her situation.
Questions This Study Couldn't Answer: Current Access, Long-Term Outcomes, and Broader Populations
- Whether there is a currently marketed Canadian prescription tesamorelin product after the Egrifta DIN cancellations.
- Whether findings in HIV-associated abdominal fat accumulation apply to people without HIV.
- Whether CT or MRI changes lead to fewer clinical events, better daily function, or durable outcomes beyond the trial periods.
- How results differ by menopausal status, hormone therapy, or other sex-specific factors.
- Whether the company involvement in the phase 3 programme influenced any aspect of interpretation; disclosure provides context but cannot answer that question by itself.
Future Research: The Studies Needed Beyond HIV-Associated Abdominal Fat
Confidence for the broader tesamorelin canada search would rise with independently funded randomized trials in non-HIV populations. Those studies would need longer follow-up, clear reporting of discontinuations and adverse events, and results separated by sex and menopausal status. Patient-important outcomes, rather than imaging alone, would make the evidence more useful in real life.
Research Use And Availability
Nuforme lists tesamorelin as a research material in Canada. It is designated for research use only and is not presented here as a currently marketed Canadian prescription drug or as a substitute for clinical care. The evidence discussed above is human clinical research in a defined HIV population; it should not be treated as evidence of an outcome in other settings.
Final Thoughts: The Honest Answer Behind Tesamorelin Canada
Tesamorelin has been tested in people, and the strongest trials recorded reductions in CT-measured visceral abdominal fat among adults with HIV-associated abdominal fat accumulation. That is more substantive than a laboratory-only evidence base. But a historic Canadian drug authorization does not establish current marketing, and the trials do not answer the broader midlife weight-management question that often sits behind a search for tesamorelin canada.
Frequently asked questions
- Was tesamorelin ever authorized as a prescription drug in Canada?
- Yes. Health Canada issued Egrifta, a tesamorelin prescription product, a Notice of Compliance on April 29, 2014. Current Drug Product Database entries list the relevant Egrifta DINs as cancelled, so that historic authorization should not be treated as evidence of current marketing.
- Did the tesamorelin trials show weight loss?
- The largest trials focused on visceral fat measured by CT scan in people with HIV-associated abdominal fat accumulation. In the pooled phase 3 analysis, BMI did not differ significantly between tesamorelin and placebo, so the findings should not be summarized as general weight-loss evidence.
- Does the research apply to menopause-related abdominal weight gain?
- Not on the evidence reviewed here. Women were a minority in the largest trials, and menopausal status and hormone-therapy use were not reported. The studies were conducted in a specific HIV clinical population, not in people experiencing menopausal body-composition changes.
- How strong is the human evidence for tesamorelin?
- It is relatively strong for its narrow research setting: several placebo-controlled human trials measured visceral abdominal fat in adults with HIV. It remains limited for people without HIV, for long-term clinical outcomes, and for sex- and menopause-specific questions.
References
Peer-reviewed sources cited in this article. Nuforme products are research materials; these studies are provided for literature context and are not claims about any product.
- [1]Falutz J, Allas S, Blot K, et al. Metabolic Effects of a Growth Hormone–Releasing Factor in Patients with HIV. New England Journal of Medicine. 2007;357:2359-2370. doi:10.1056/NEJMoa072375.
Human randomized, double-blind, placebo-controlled trial · n = 412 randomized; 275 tesamorelin and 137 placebo · 26 weeks · Primary endpoint: percentage change in CT-measured visceral adipose tissue—fat stored inside the abdomen around internal organs, not body weight alone.
At 26 weeks, visceral adipose tissue fell by 15.2% in the tesamorelin group and rose by 5.0% with placebo. The trial reported a 20.5% overall discontinuation rate, with no statistically significant difference between groups.
- [2]Falutz J, Mamputu JC, Potvin D, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. Journal of Clinical Endocrinology & Metabolism. 2010;95:4291-4304. doi:10.1210/jc.2010-0490.
Pooled analysis of two human phase 3 randomized, double-bl · n = 806 randomized; 543 tesamorelin and 263 placebo in the 26 · 26-week blinded phase; eligible participants entered a further 26-week blinded extension · Primary endpoint: percentage change in CT-measured visceral adipose tissue at week 26.
At 26 weeks, the estimated treatment effect on visceral adipose tissue was -15.4% versus placebo. Body-mass index did not differ significantly between groups. The VAT result was reported as similar in the male and female subgroups, but the female subgroup was small.
- [3]Stanley TL, Feldpausch MN, Oh J, et al. Effect of Tesamorelin on Visceral Fat and Liver Fat in HIV-Infected Patients With Abdominal Fat Accumulation: A Randomized Clinical Trial. JAMA. 2014;312:380-389. doi:10.1001/jama.2014.8334.
Human randomized, double-blind, placebo-controlled trial · n = 50 randomized; 28 tesamorelin and 22 placebo; 48 received at · 6 months · Co-primary endpoints: change in CT-measured visceral adipose tissue and magnetic-resonance-spectroscopy liver-fat measurement.
Over six months, the between-group difference in visceral fat change was -42 cm². Liver-fat measurement also fell more with tesamorelin than placebo. Fasting glucose rose transiently at two weeks in the tesamorelin arm, while between-group glucose differences at six months were not statistically significant.
- [4]Stanley TL, Fourman LT, Feldpausch MN, et al. Effects of Tesamorelin on Nonalcoholic Fatty Liver Disease in HIV: A Randomized, Double-Blind, Multicenter Trial. The Lancet HIV. 2019;6:e821-e830. doi:10.1016/S2352-3018(19)30338-8.
Human randomized, double-blind, placebo-controlled multicent · n = 61 enrolled; 30 assigned tesamorelin and 30 placebo, with an · 12-month blinded phase, followed by a 6-month open-label phase · Primary endpoint: change in liver fat measured as hepatic fat fraction by proton magnetic-resonance spectroscopy. Primary safety endpoint: glucose.
Among people with HIV and MRI-defined fatty liver, the estimated absolute between-group difference in liver-fat change at 12 months was -4.1 percentage points. Glucose measures did not differ between groups at 12 months; localized injection-site complaints were more common with tesamorelin.
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