# Tesofensine

Tesofensine has 14 registered human trials. It is marketed for 2 different uses.

**In short**

- 14 registered human trials exist for Tesofensine.
- Tesofensine is not FDA-approved for any use.
- What has actually been studied: alzheimer disease, obesity, confirmed genetic diagnosis of prader-willi syndrome.
- Last checked against ClinicalTrials.gov on 2026-07-27.

## What it is sold for

- Weight loss
- Appetite suppression

## What has actually been tested

- Alzheimer Disease
- Obesity
- Confirmed Genetic Diagnosis of Prader-Willi Syndrome
- Prader-Willi Syndrome
- Hypothalamic Obesity
- Phase 1
- Hypothalamic Injury-induced Obesity (HIO)
- Type 2 Diabetes Mellitus
- Healthy Male Subjects
- Parkinson Disease
- Atrial Fibrillation (AF)

## Every trial on record

| Trial ID | Title | Condition | Phase | Status | Enrolled |
|---|---|---|---|---|---|
| [NCT00153010](https://clinicaltrials.gov/study/NCT00153010) | An Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's Type | Alzheimer Disease | Phase 2 | COMPLETED | 430 |
| [NCT00428415](https://clinicaltrials.gov/study/NCT00428415) | Effect of Tesofensine on Energy Balance in Humans. | Obesity | Phase 2 | COMPLETED | 32 |
| [NCT03149445](https://clinicaltrials.gov/study/NCT03149445) | Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS) | Confirmed Genetic Diagnosis of Prader-Willi Syndrome | Phase 2 | COMPLETED | 18 |
| [NCT00394667](https://clinicaltrials.gov/study/NCT00394667) | Effect of Tesofensine on Weight Reduction in Patients With Obesity. | Obesity | Phase 2 | COMPLETED | 200 |
| [NCT05198362](https://clinicaltrials.gov/study/NCT05198362) | Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome | Prader-Willi Syndrome | Phase 2 | WITHDRAWN | 0 |
| [NCT05147415](https://clinicaltrials.gov/study/NCT05147415) | Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO) | Hypothalamic Obesity | Phase 2 | WITHDRAWN | 0 |
| [NCT03488719](https://clinicaltrials.gov/study/NCT03488719) | A Study to Examine the Effect of Tesofensine and Metoprolol on the 24-hour Mean Heart Rate | Phase 1 | Phase 1 | COMPLETED | 37 |
| [NCT03845075](https://clinicaltrials.gov/study/NCT03845075) | 48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO) | Hypothalamic Injury-induced Obesity (HIO) | Phase 2 | COMPLETED | 21 |
| [NCT02737891](https://clinicaltrials.gov/study/NCT02737891) | Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus | Type 2 Diabetes Mellitus | Phase 2 | COMPLETED | 60 |
| [NCT03286829](https://clinicaltrials.gov/study/NCT03286829) | Study to Investigate the Pharmacokinetic Profile | Healthy Male Subjects | Phase 1 | COMPLETED | 60 |
| [NCT00148512](https://clinicaltrials.gov/study/NCT00148512) | A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations | Parkinson Disease | Phase 2 | COMPLETED | 254 |
| [NCT00481104](https://clinicaltrials.gov/study/NCT00481104) | Evaluation of Long Term Safety of Tesofensine in Patients With Obesity | Obesity | Phase 2 | COMPLETED | 140 |
| [NCT05712200](https://clinicaltrials.gov/study/NCT05712200) | Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76) | Atrial Fibrillation (AF) | Phase 3 | RECRUITING | 2500 |
| [NCT00148486](https://clinicaltrials.gov/study/NCT00148486) | A Fourteen-Week Placebo-Controlled Dose-Response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE) | Parkinson Disease | Phase 2 | COMPLETED | 261 |

## Common questions

**How many human trials does Tesofensine have?**
14, each listed above with a link to its original record.

**Is Tesofensine FDA approved?**
No. It is not approved by the FDA for any indication.

**Where does this data come from?**
ClinicalTrials.gov. We count interventional human studies only. Every trial
links to its original record.

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*Automated aggregation from public registries. Not medical advice. No physician
has reviewed this page. Source: https://www.whatsactuallyknown.com/compounds/tesofensine*