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TeHuman trials

Tesofensine protocol

Tesofensine is a daily pill that acts on brain chemicals to cut appetite. It was tested in a 2008 phase 2 trial and in later trials. No major regulator has approved it.

Not approved in the US or EUMexico: application had not been approved as of Nov 2024 (partner company report)
ProtocolMixingResultsSide effectsHow it worksSources

The protocol at a glance

In the main phase 2 trial, 203 adults took a pill once a day for 24 weeks, at 0.25, 0.5 or 1.0 mg, along with a reduced-calorie diet.

Daily pill amountHow long
0.25 mg24 weeks
0.5 mg24 weeks
1.0 mg24 weeks
RoutePill by mouth, once a day

From Astrup A et al. Lancet 2008 (NCT00394667). This is a trial schedule. There is no label.

Community reports

This is not a peptide, and community posts mostly repeat the 2008 trial doses. This is community talk.

What people say they do, collected from community discussions. Not tested in a trial; shown so you can compare it with the evidence above.

Mixing

No mixing table here: this one is used as a capsule, nasal spray or skin product, or has no human amount to calculate from. The general mixing calculator works for any vial.

What the trials found

Phase 2 trial in Denmark, 203 adults with obesity, 24 weeks, with a diet. The numbers are the extra weight loss compared with diet plus placebo (placebo group lost 2.0%):

-10.6%1.0 mg daily, extra
-9.2%0.5 mg daily, extra
-4.5%0.25 mg daily, extra
-2.0%Diet plus placebo

Astrup A et al. Lancet 2008;372:1906-13 (PubMed 18950853), NCT00394667. The authors said phase 3 trials were needed.

Side effects

  • Common side effects were dry mouth, nausea, constipation, hard stools, diarrhea and trouble sleeping.
  • Heart rate went up by 7.4 beats per minute on 0.5 mg, compared with placebo. Blood pressure did not rise significantly on 0.25 or 0.5 mg.

How it works

Brain chemical reuptake

It blocks the re-absorption of noradrenaline, dopamine and serotonin in the brain, which lowers appetite.

Sources

  • Astrup A et al. Lancet 2008, tesofensine in obese patients, NCT00394667 (PubMed 18950853)
  • ClinicalTrials.gov NCT00394667
  • Saniona AB / Inderes release: Mexican application for tesofensine not yet approved (Nov 2024)