Survodutide Research & Reconstitution: BAC Water, Studies & Evidence
Survodutide (BI 456906) is an investigational dual glucagon receptor and GLP-1 receptor agonist being studied in obesity, type 2 diabetes, metabolic dysfunction-associated steatohepatitis (MASH), and related metabolic conditions. Phase 2 and emerging phase 3 evidence provide substantial human clinical data, but survodutide is not presented here as an FDA-approved medicine or as having an FDA-approved human dosage.
Clinical Research Snapshot
Survodutide Mechanism & Clinical Research Overview
Survodutide BAC Water & Concentration Reference
Survodutide is investigational and does not have an FDA-approved commercial labeling framework establishing a universal BAC-water reconstitution procedure for a research vial.
Clinical-trial publications describe study formulations and administration procedures, but those study-specific formulations should not automatically be treated as instructions for an unrelated research material.
Research Concentration Examples — Mathematical Reference
The governing equation is:
Total vial quantity ÷ final liquid volume = concentration
Example: a hypothetical research vial containing 10 mg of compound with a final liquid volume of 2 mL corresponds mathematically to a concentration of 5 mg/mL.
| Research vial quantity | Final liquid volume | Calculated concentration | Mathematical reference |
|---|---|---|---|
| 5 mg | 1 mL | 5 mg/mL | Quantity divided by volume |
| 5 mg | 2 mL | 2.5 mg/mL | Quantity divided by volume |
| 10 mg | 1 mL | 10 mg/mL | Quantity divided by volume |
| 10 mg | 2 mL | 5 mg/mL | Quantity divided by volume |
| 15 mg | 1.5 mL | 10 mg/mL | Quantity divided by volume |
| 30 mg | 3 mL | 10 mg/mL | Quantity divided by volume |
Calculate a Custom Concentration
Use the BacScience universal BAC-water calculator for concentration mathematics.
What Is Survodutide?
Survodutide, also known as BI 456906, is an investigational peptide designed to activate both the glucagon receptor and the glucagon-like peptide-1 receptor.
Unlike selective GLP-1 receptor agonists, survodutide combines GLP-1-receptor activity with glucagon-receptor activity. This dual mechanism is being investigated for effects on body weight, glycemic control, energy metabolism and liver-related endpoints.
Human clinical development has included randomized phase 2 studies in obesity, type 2 diabetes and MASH, followed by phase 3 programs in obesity and obesity with type 2 diabetes.
Mechanism of Action
Survodutide is a dual agonist of the glucagon receptor (GCGR) and GLP-1 receptor (GLP-1R). The GLP-1 component is associated with incretin-related metabolic effects, while glucagon-receptor activity is being investigated for effects on energy expenditure, lipid metabolism and other metabolic pathways.
The combined receptor activity is one reason survodutide has been investigated beyond glucose control, including in obesity and metabolic dysfunction-associated steatohepatitis.
FDA / Regulatory Status
Survodutide is investigational. It is not presented on this page as an FDA-approved medication and there is no FDA-approved survodutide dosage or labeled indication to report.
Approved Dosage vs. Doses Studied in Clinical Trials
Survodutide Clinical Development History
Early clinical studies evaluated survodutide in metabolic disease, including type 2 diabetes. Subsequent phase 2 programs examined obesity and MASH, generating evidence for both metabolic and liver-related outcomes.
The obesity program progressed into phase 3 SYNCHRONIZE studies. Published 2026 results from SYNCHRONIZE-1 reported significant weight reduction with 3.6 mg and 6.0 mg survodutide compared with placebo over 76 weeks.
Phase 3 development also includes SYNCHRONIZE-2 in participants with overweight or obesity and type 2 diabetes.
Major Human Clinical Trials
The following table emphasizes randomized human studies and current clinical-development evidence. Trial doses are reported for research interpretation only.
| Trial | Phase | Population | N | Dose studied | Route | Frequency | Duration | Primary outcome / key finding | Source |
|---|---|---|---|---|---|---|---|---|---|
| Phase 2 T2D NCT04153929 |
2 | Type 2 diabetes on metformin | 413 randomized | Up to 0.3, 0.9, 1.8 or 2.7 mg once weekly; additional twice-weekly groups | SC | Weekly / twice weekly | 16 weeks | Survodutide reduced HbA1c and body weight, with dose-related effects and predominantly gastrointestinal adverse events. | PubMed |
| Obesity Phase 2 NCT04667377 |
2 | Overweight / obesity without diabetes | 387 enrolled | 0.6, 2.4, 3.6, 4.8 mg | SC | Once weekly | 46 weeks | Mean body-weight changes were −6.2%, −12.5%, −13.2% and −14.9% for the 0.6, 2.4, 3.6 and 4.8 mg groups, respectively, versus −2.8% with placebo. | PubMed |
| MASH Phase 2 NCT04771273 |
2 | Biopsy-confirmed MASH with F1–F3 fibrosis | 293 | 2.4, 4.8, 6.0 mg | SC | Once weekly | 48 weeks | Histologic improvement in MASH without worsening of fibrosis occurred more frequently in survodutide groups than placebo. | PubMed |
| SYNCHRONIZE-1 NCT06066515 |
3 | Obesity / overweight without type 2 diabetes | 726 | 3.6 and 6.0 mg | SC | Once weekly | 76 weeks | Mean body-weight change was −12.2% with 3.6 mg and −13.0% with 6.0 mg versus −5.4% with placebo at week 76. | NEJM / PubMed |
| SYNCHRONIZE-2 NCT06066528 |
3 | Overweight / obesity with type 2 diabetes | 755 | 3.6 and 6.0 mg | SC | Once weekly | 76 weeks | Phase 3 randomized evaluation of survodutide versus placebo in participants with overweight or obesity and type 2 diabetes. | ClinicalTrials.gov |
| Cirrhosis PK / Safety Study NCT05296733 |
2 | Participants with compensated or decompensated cirrhosis and overweight / obesity cohorts | 41 in multiple-dose cohorts | Escalated study doses up to 6.0 mg | SC | Once weekly | 28 weeks | Study evaluated pharmacokinetics and safety and reported reductions in several liver-related and metabolic measures. | PubMed |
Doses Studied in Survodutide Clinical Research
Survodutide has been studied using different dose-escalation schemes depending on the indication and trial. Published phase 2 obesity research evaluated 0.6–4.8 mg once weekly, while later phase 3 obesity studies evaluated 3.6 mg and 6.0 mg once-weekly treatment groups.
| Research context | Doses documented | Status |
|---|---|---|
| Type 2 diabetes — Phase 2 | Up to 0.3, 0.9, 1.8 or 2.7 mg once weekly; additional 1.2 and 1.8 mg twice-weekly groups were evaluated. | TRIAL DOSES |
| Obesity — Phase 2 | 0.6, 2.4, 3.6 and 4.8 mg once weekly. | TRIAL DOSES |
| MASH — Phase 2 | 2.4, 4.8 and 6.0 mg once weekly. | TRIAL DOSES |
| SYNCHRONIZE-1 — Phase 3 | 3.6 and 6.0 mg once weekly. | PHASE 3 |
| SYNCHRONIZE-2 — Phase 3 | 3.6 and 6.0 mg once weekly. | PHASE 3 |
| FDA-approved dosage | No FDA-approved survodutide dosage exists. | NOT APPROVED |
Trial doses are reported to describe the clinical literature. They are not individualized dosing recommendations.
Survodutide Research Outcomes
Body Weight
In the 46-week phase 2 obesity study, mean body-weight reductions increased across the studied survodutide groups. The planned-treatment analysis reported −6.2%, −12.5%, −13.2% and −14.9% changes with 0.6, 2.4, 3.6 and 4.8 mg, respectively, compared with −2.8% with placebo.
Phase 3 Obesity Evidence
The 2026 SYNCHRONIZE-1 publication reported mean body-weight changes at week 76 of −12.2% with 3.6 mg and −13.0% with 6.0 mg survodutide, compared with −5.4% with placebo.
Glycemic Control
In a randomized phase 2 type 2 diabetes study, survodutide produced reductions in HbA1c across several studied dose groups. Body-weight reduction also showed a dose-related pattern, with the highest twice-weekly group producing an approximately 8.7% mean reduction in body weight at week 16.
MASH and Liver Outcomes
A 48-week phase 2 MASH trial randomized 293 participants with biopsy-confirmed MASH and fibrosis stages F1 through F3. Histologic improvement in MASH without worsening of fibrosis occurred in 47%, 62% and 43% of participants receiving 2.4, 4.8 and 6.0 mg, respectively, compared with 14% with placebo.
Dose-Response Relationships
Dose-response patterns have differed according to endpoint and indication. The phase 2 obesity trial showed progressively greater mean weight reduction across several dose groups, while the MASH study's primary histologic endpoint was modeled using a nonlinear dose-response relationship.
Adverse Events & Safety Findings
Gastrointestinal adverse events are prominent across published survodutide trials. In the phase 2 obesity study, gastrointestinal adverse events occurred in approximately 75% of survodutide-treated participants compared with 42% of placebo recipients.
In the 2026 SYNCHRONIZE-1 phase 3 study, gastrointestinal symptoms occurred in 80.9% of participants receiving 3.6 mg and 89.7% of participants receiving 6.0 mg, compared with 47.9% receiving placebo. The published report characterized these events as typically mild to moderate.
In the phase 2 MASH study, nausea occurred in 66% of participants receiving 2.4 mg, diarrhea in 49%, and vomiting in 41%; corresponding placebo rates were 23%, 23% and 4%.
Research Limitations & What Remains Unknown
Survodutide remains under clinical development. Although phase 2 studies and emerging phase 3 results provide substantial evidence, trial results remain population- and protocol-specific.
Important unanswered questions include long-term safety, comparative effectiveness against established metabolic therapies, optimal treatment strategies, durability of treatment effects, long-term liver outcomes and the eventual regulatory status of individual indications.
MASH and liver-related results are particularly important to interpret carefully because histologic and biomarker endpoints do not by themselves establish long-term clinical outcomes.
The transition from phase 2 evidence to phase 3 evidence also does not guarantee regulatory approval. Regulatory decisions depend on the totality of efficacy, safety, manufacturing and other evidence submitted to the applicable authority.
BAC Water / Reconstitution Considerations
There is no universal BAC-water volume for “survodutide” as a compound.
Survodutide is investigational, and published clinical trials should not be interpreted as establishing a universal preparation method for unrelated research vials.
General Concentration Formula
Total vial quantity ÷ final liquid volume = concentration
For example, 10 mg divided by 2 mL equals 5 mg/mL mathematically. This is a concentration calculation only and does not establish an appropriate preparation, administration volume or human dose.
| Quantity | Final volume | Mathematical concentration |
|---|---|---|
| 5 mg | 1 mL | 5 mg/mL |
| 10 mg | 2 mL | 5 mg/mL |
| 15 mg | 1.5 mL | 10 mg/mL |
| 20 mg | 2 mL | 10 mg/mL |
| 30 mg | 3 mL | 10 mg/mL |
Survodutide Concentration Calculator
Use the BacScience universal calculator for mathematical concentration calculations.
Continue Your Research
Survodutide Research FAQ
Is survodutide FDA approved?
No. Survodutide (BI 456906) is an investigational compound in clinical development. It does not have an FDA-approved indication or FDA-approved dosage.
What is survodutide?
Survodutide is an investigational dual agonist of the glucagon receptor and GLP-1 receptor being studied in obesity, type 2 diabetes, MASH and related metabolic conditions.
What receptors does survodutide activate?
Survodutide activates both the glucagon receptor and the glucagon-like peptide-1 receptor.
What survodutide doses have been studied?
Clinical studies have evaluated different regimens. The phase 2 obesity study evaluated 0.6, 2.4, 3.6 and 4.8 mg once weekly, while later phase 3 obesity studies evaluated 3.6 and 6.0 mg once weekly.
What did the phase 2 obesity study find?
At week 46, mean body-weight changes were approximately −6.2%, −12.5%, −13.2% and −14.9% with 0.6, 2.4, 3.6 and 4.8 mg, respectively, compared with −2.8% with placebo.
What did the phase 3 SYNCHRONIZE-1 study find?
At week 76, mean body-weight change was approximately −12.2% with 3.6 mg and −13.0% with 6.0 mg survodutide compared with −5.4% with placebo in adults with obesity without diabetes.
Has survodutide been studied for MASH?
Yes. A randomized phase 2 trial enrolled 293 participants with biopsy-confirmed MASH and fibrosis stages F1 through F3 and evaluated 2.4, 4.8 and 6.0 mg once weekly for 48 weeks.
How much BAC water should be used for survodutide?
There is no universal BAC-water volume that applies to every survodutide research material. Concentration mathematics depends on the total quantity and final liquid volume, while an actual preparation method depends on the specific formulation and experimental requirements.
How do you calculate survodutide concentration?
Divide total compound quantity by final liquid volume. For example, 10 mg divided by 2 mL equals 5 mg/mL mathematically. This is a concentration calculation, not a dosing recommendation.
Is a clinical-trial dose a recommended dose?
No. A clinical-trial dose describes the protocol used in a particular study population. It should not be converted into a personalized treatment recommendation.
What are the most common adverse events reported with survodutide?
Gastrointestinal adverse events, including nausea, diarrhea and vomiting, are prominent in published clinical trials. Frequency varies according to dose, study population and treatment period.
Where can researchers verify current survodutide clinical status?
Current clinical status should be checked using ClinicalTrials.gov, PubMed and the primary journal publications. Regulatory status should be verified through the applicable regulatory authority.
Scientific References
- le Roux CW, et al. Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial. Lancet Diabetes & Endocrinology. 2024. PubMed .
- Blüher M, et al. Dose-response effects on HbA1c and bodyweight reduction of survodutide, a dual glucagon/GLP-1 receptor agonist, compared with placebo and open-label semaglutide in people with type 2 diabetes. Diabetologia. 2024. PubMed .
- Sanyal AJ, et al. A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis. New England Journal of Medicine. 2024. PubMed .
- le Roux CW, et al. Survodutide Once Weekly for the Treatment of Adults with Obesity. New England Journal of Medicine. 2026. PubMed .
- ClinicalTrials.gov. SYNCHRONIZE-1: NCT06066515. ClinicalTrials.gov .
- ClinicalTrials.gov. SYNCHRONIZE-2: NCT06066528. ClinicalTrials.gov .
- Ekinci EI, et al. Dual Glucagon and GLP-1 Receptor Agonist Survodutide Improves Biomarkers of Beta-Cell Function and Insulin Sensitivity. Diabetes, Obesity and Metabolism. 2026. PubMed .
- Survodutide pharmacokinetic and safety research in cirrhosis. Journal of Hepatology / related clinical publication. PubMed .
Last scientifically reviewed: September 11, 2026. This page is an educational clinical-research reference and is not medical advice, a prescribing guide, or a human treatment protocol.