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How Long Does Kybella Last

Written & medically reviewed by the Dermapedia team
At a Glance

The longest peer-reviewed follow-up after Kybella is three years. It was a non-treatment follow-up of people from the two approval trials. At year 3, 82.4 per cent of clinician-rated responders were still rated as responders, against 65.0 per cent of the people who had responded to placebo injections. That placebo figure is the number to keep in view.

The "four years" you will see quoted is not a study you can read. It appears in a review written by authors affiliated with the developer, and traces back to a long-term follow-up of an early-phase group presented at a conference in 2011 with two years of data, announced in a company press release. No peer-reviewed publication of four-year follow-up data exists. Three years is the citable maximum.

Fat cells that are destroyed do not come back, and that is the real basis for durability. The drug is a detergent that ruptures fat-cell membranes; tissue samples taken up to 28 days after injection show fat-cell destruction and shrunken fat lobules. But the word "permanent" does not appear anywhere in the FDA-approved label. What the label claims is improvement in the appearance of fullness, not removal of fat.

Destroyed cells not returning is not the same as your chin not changing. The fat cells that survive in the treated area can still enlarge if you gain weight. That is standard adipose physiology rather than something measured in people treated with this drug, and it should be read as reasoning, not as a finding.

Only responders were followed for three years, and only by eye. Enrolment in the follow-up study was restricted to people who had already improved by 12 weeks after their last trial treatment, so it describes what happens to people it already worked for. No MRI or 3D imaging was done after 12 weeks anywhere in the programme. The three-year evidence is rating scales.

On patients' own strict ratings, the drug and placebo groups were indistinguishable at every year. Maintenance of a two-grade patient-rated improvement was 59.5 per cent for the drug and 70.0 per cent for placebo at year 3. The study's authors acknowledge a substantial placebo effect in how people rate their own necks over time.

Key Facts

Longest peer-reviewed follow-up3 years after the last treatment
Design of that studymulticentre, double-blind, non-treatment follow-up of participants from the two approval trials, 224 enrolled and 200 completing
Who could enrolonly people whose clinician had rated them improved 12 weeks after their last trial treatment
Clinician-rated response still present at year 382.4 per cent of treated responders, against 65.0 per cent of placebo responders
Same measure at year 1 and year 286.4 against 56.8 per cent, and 90.6 against 73.8 per cent
Stricter two-grade clinician response at year 365.8 per cent treated against 33.3 per cent placebo
Two-grade patient-rated response at year 359.5 per cent treated against 70.0 per cent placebo
Satisfaction74 per cent of treated patients satisfied at 12 weeks were still satisfied at year 3
Objective imaging beyond 12 weeksnone anywhere in the development programme
The four-year figureconference and company material, with no peer-reviewed publication
The word permanent in the FDA labeldoes not appear
Fundingthe three-year follow-up was sponsored by Allergan, which also performed the data analyses

What the question is really asking

"How long does it last" bundles two different questions. One is whether the fat cells the drug destroyed can regrow. The other is whether the visible result under your chin holds. They have different answers and different quality of evidence behind them.

The first is a biology question, and the biology is reasonably clear. The second is a follow-up question, and the follow-up runs to three years, in a selected group, measured by eye.

The three-year study

The trials that supported approval followed people for 24 weeks after their last treatment. A separate study then re-enrolled participants and followed them, without further treatment, for three more years across 13 US and 2 Canadian sites. Of 257 people screened, 224 enrolled and 200 completed.

Its primary measure was whether a clinician-rated one-grade improvement was still there. The results, drug against placebo: year 1, 86.4 against 56.8 per cent. Year 2, 90.6 against 73.8 per cent. Year 3, 82.4 against 65.0 per cent. On the stricter two-grade clinician measure, among people who had achieved it originally: 75.0 against 18.2 per cent at year 1, 72.5 against 33.3 per cent at year 2, and 65.8 against 33.3 per cent at year 3.

Satisfaction held up too. Of treated patients who were satisfied at 12 weeks, 74 per cent were still satisfied at year 3. Skin laxity was unchanged or improved at year 3 in 75 per cent of treated patients and 74 per cent of placebo patients.

No new treatment-related side effects appeared over the three years, and every treatment-area effect reported had first appeared during the original trials.

The study was sponsored by Allergan, and Allergan performed the data analyses: One author was an employee of AbbVie, and the others were company investigators or consultants. That does not make the numbers wrong. It does mean they are not independent, and the paper's own limitations section names selection bias, attrition bias and small numbers in the two-grade subgroups.

What the three-year study could not tell you

Three limits matter more than the headline.

Only responders were let in: You had to have improved by 12 weeks after your last trial treatment to enrol. So the study answers "if it worked for you, does it hold?" — not "will it work and hold for me?". Across the original trials, 66 to 70 per cent achieved a one-grade improvement on the combined clinician and patient scales, and only 13 to 19 per cent achieved a two-grade improvement.

Nothing was measured objectively: The trials did use MRI, but only in a subgroup of 449 people and only at 12 weeks, where 43 per cent of treated patients achieved at least a 10 per cent reduction in fat volume against 5 per cent on placebo. After 12 weeks, no MRI, no ultrasound and no 3D imaging was done anywhere in the programme. The follow-up authors list this as a limitation themselves. The three-year evidence is people looking at necks and assigning grades.

The placebo group held its result too: Between 56.8 and 73.8 per cent of people who had "responded" to placebo injections were still rated as responders years later. Since placebo injections do not destroy fat, that number is measuring something else: raters drifting, people's own memory of their baseline, ordinary variation in how a neck looks. Anywhere between half and two thirds of the maintained rating in the treated group could be the same effect. The gap between the groups is the drug's contribution, and at year 3 that gap is 17 percentage points.

The pattern is sharpest on the patients' own strict ratings. Maintenance of a two-grade patient-rated improvement was 59.0 against 63.6 per cent at year 1, 57.5 against 60.0 at year 2 and 59.5 against 70.0 at year 3. No separation at all, and the placebo group numerically ahead. The authors say plainly that there is a substantial placebo effect in patients' own ratings.

Where the "four years" comes from

A review article published in 2016, written by authors affiliated with the developer, states that treatment response is maintained "up to 4 years" after the last treatment. That sentence is the source of nearly every four-year claim online.

Behind it is a long-term follow-up of an early-phase group, planned to run five years, first presented at a dermatologic surgery meeting in 2011 with two years of data and announced in a company press release. There is no peer-reviewed publication of four-year follow-up data.

That is not an accusation that the four-year data are wrong. It is a statement about what can be checked. A conference presentation and a press release are not a paper you can read, and a claim you cannot inspect should not carry the same weight as one you can. Three years is the number a page like this can stand behind.

There is also a shorter but useful study: a 12-month open-label study in 165 people, with no control group, in which 90.4 per cent of clinician-rated responders and 80.7 per cent of patient-rated responders still had their improvement at 12 months. Open-label and uncontrolled, so it cannot separate the drug from everything else, but it points the same direction over the first year.

What "the fat cells are destroyed" means

The label's whole mechanism section is one sentence: the drug physically destroys the cell membrane, causing the cell to burst. Tissue examined 28 days after injection shows shrunken fat lobules, thickened fibrous partitions and new small blood vessels, with all changes confined to the fat layer.

A cell that has burst is gone: In adults, fat-cell number is broadly stable, and weight change is mostly cells getting bigger or smaller rather than new cells appearing. That is why "the cells do not come back" is a reasonable statement.

Here is what it does not mean. It does not mean the label claims permanence — the word does not appear in it, and the approved indication is improvement in the appearance of fullness, not fat removal. It does not mean every fat cell in the treated area was destroyed; the average trial patient received 25.3 mL in total out of a permitted maximum of 60 mL, and fewer than half achieved even a 10 per cent measured reduction in fat volume. And it does not mean the area is frozen in place. Cells you still have can grow.

What happens if you gain weight

The remaining fat cells in a treated area can enlarge, in the same way fat cells anywhere enlarge with weight gain. This is physiological reasoning, not a documented finding: no study has measured fat-cell size in a Kybella-treated neck after subsequent weight gain.

The nearest hard evidence comes from a different procedure. The only randomised trial of whether fat returns after it is removed studied small-volume liposuction in 32 non-obese women. At one year, overall body fat had been restored, and the pattern had shifted — thigh fat stayed reduced while abdominal fat came back. A much larger single-surgeon photographic series of 301 liposuction procedures concluded the opposite, that there was no evidence of fat regrowth. Neither studied injection lipolysis, and the two disagree with each other, so anyone telling you fat definitely does or definitely does not come back somewhere else is extrapolating.

The practical version: destroying fat cells under the chin does not change what your body does with surplus calories.

What makes a durable result more likely

Two things in the data are worth knowing before you start.

Dose and sessions: The label permits up to six treatments at least a month apart. In the trials, the median number of sessions to a combined clinician-and-patient response was 3, and 59 per cent of subjects went through all six. In a real-world private-practice series of 100 patients, the author concluded that at least two sessions were needed to reach the aesthetic goal. Stopping after one because the swelling was unpleasant is a common way to end up with a result that does not look like it lasted.

What the fullness is made of: The trials excluded people with excessive loose skin under the chin, and the label tells prescribers to give careful consideration to anyone with marked laxity or prominent neck bands. If part of what you see is skin rather than fat, removing fat will not fix that part, and it will not become durable by repeating the treatment.

Ageing does not stop after treatment either. Nothing in the three-year data speaks to what happens at year five or year ten, because nobody looked.

Recovery, side effects and what the first month is actually like are covered on the Kybella recovery and Kybella swelling day by day pages.

Questions people ask

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Is Kybella permanent?The fat cells the drug destroys do not regrow, and that is the basis for the claim. But the word "permanent" does not appear in the FDA-approved label, which claims improvement in the appearance of fullness rather than fat removal. The longest peer-reviewed follow-up is three years, and it measured ratings rather than fat volume.
How long do the results actually last?Three years is the longest published follow-up. In it, 82.4 per cent of clinician-rated responders were still rated as responders at year 3, against 65.0 per cent of placebo responders. Only people who had already responded could enrol, and no imaging was done after 12 weeks.
Is there a four-year study?Not a published one. The four-year figure comes from a review by authors affiliated with the developer, tracing to a conference presentation in 2011 with two years of data and a company press release. No peer-reviewed four-year follow-up has been published.
Will the fat come back if I gain weight?The destroyed cells do not return, but the fat cells that remain in the area can get bigger with weight gain. That is standard physiology rather than something measured after this drug. The only randomised study of fat returning after removal was in liposuction patients, and a large observational series reached the opposite conclusion, so the honest answer is that this specific question has not been settled for injection lipolysis.
Why did the placebo group keep their results too?That is the most useful oddity in the three-year data. Between 56.8 and 73.8 per cent of placebo responders were still rated as responders years later, and placebo injections do not destroy fat. It shows how much of a maintained rating is rater drift and ordinary variation, and it is why the gap between groups matters more than the treated group's own number.
Do I need touch-up sessions later?No published study has tested retreatment after a durable result. The label allows up to six treatments spaced at least a month apart, and the three-year follow-up deliberately gave no further treatment. Whether a top-up years later is useful has not been studied.
Does the skin under my chin sag once the fat is gone?In the three-year data, skin laxity was unchanged or improved at year 3 in 75 per cent of treated patients and 74 per cent of placebo patients. Note that people with excessive laxity were excluded from the original trials, so that finding applies to people who did not have much loose skin to begin with.
How many sessions does it take to get a lasting result?In the trials the median number of sessions to a combined clinician and patient response was 3, and 59 per cent of subjects had all six the protocol allowed. A real-world series of 100 patients concluded that at least two sessions were needed to reach the goal.

References

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Humphrey S, Cohen JL, Bhatia AC, Green LJ, Green JB, Bowen B. Improvements in Submental Contour up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials. Aesthet Surg J. 2021;41(11):NP1532-9. https://pmc.ncbi.nlm.nih.gov/articles/PMC8520020/
The longest peer-reviewed follow-up. Multicentre, double-blind, non-treatment follow-up of participants from the two approval trials, 224 enrolled and 200 completing, restricted to people already rated as responders 12 weeks after their last trial treatment. Source for every maintenance figure used here, for the 74 per cent satisfaction at year 3, for skin laxity unchanged or improved in 75 against 74 per cent, and for the authors' own statement that no MRI or 3D photography was performed. Sponsored by Allergan, which performed the data analyses; one author is an AbbVie employee and the others are company investigators or consultants.
Dayan SH, Humphrey S, Jones DH, et al. Overview of ATX-101 (Deoxycholic Acid Injection): A Nonsurgical Approach for Reduction of Submental Fat. Dermatol Surg. 2016;42 Suppl 1:S263-70. https://pubmed.ncbi.nlm.nih.gov/27787266/
The source of the widely repeated claim that response is maintained "up to 4 years" after the last treatment. Cited here to show where the four-year figure originates: a review by authors affiliated with the developer, not a four-year study. No peer-reviewed publication of four-year follow-up data was located.
FDA drug label, KYBELLA (deoxycholic acid) injection, NDA 206333, approved 29 April 2015, label revised 10/2024. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206333
Source for the approved indication being improvement in the appearance of moderate to severe convexity or fullness associated with submental fat, for the one-sentence mechanism describing physical destruction of the cell membrane, for the absence of the word "permanent" anywhere in the label, for the dosing limits of up to six treatments at least a month apart, for the trial efficacy figures, for the MRI finding of 43 against 5 per cent achieving at least a 10 per cent volume reduction at 12 weeks, and for the instruction to give careful consideration to patients with excessive skin laxity or prominent platysmal bands.
Walker PS, Lee DR, Toth BA, Bowen B. Histological Analysis of the Effect of ATX-101 on Subcutaneous Fat: Results From a Phase 1 Open-Label Study. Dermatol Surg. 2020;46(1):70-7. https://pubmed.ncbi.nlm.nih.gov/30883481/
Phase 1 open-label study in 14 adults with tissue examined 1, 3, 7 or 28 days after injection. Source for the day 28 findings of shrunken fat lobules, thickened fibrous partitions and new small blood vessels, with all changes confined to the fat layer. Three authors were employees of the developer.
Beer K et al. J Drugs Dermatol. 2019;18(9):870-7. https://pubmed.ncbi.nlm.nih.gov/31524342/
Twelve-month open-label study in 165 people with no control group. Source for 90.4 per cent of clinician-rated and 80.7 per cent of patient-rated responders maintaining their improvement at 12 months.
Dayan SH, Schlessinger J, Beer K, et al. Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials. Aesthet Surg J. 2018;38(9):998-1010. https://pmc.ncbi.nlm.nih.gov/articles/PMC6094350/
Source for the median of 3 sessions to a combined clinician and patient response, for the mean total volume of 25.3 mL across all sessions, and for the pooled efficacy figures. Funded by Kythera Biopharmaceuticals; three authors were Kythera employees and one an Allergan employee.
Shridharani SM. Real-World Experience With 100 Consecutive Patients Undergoing Neck Contouring With ATX-101 (Deoxycholic Acid): An Updated Report With A 2-Year Analysis. Dermatol Surg. 2019;45(10):1285-93. https://pmc.ncbi.nlm.nih.gov/articles/PMC6766358/
Prospective single-centre series of 100 consecutive patients. Source for the author's conclusion that at least two treatment sessions were required to reach the aesthetic goal in private practice. The author receives support from Allergan.
Hernandez TL, Kittelson JM, Law CK, et al. Fat redistribution following suction lipectomy: defense of body fat and patterns of restoration. Obesity (Silver Spring). 2011;19(7):1388-95. https://pubmed.ncbi.nlm.nih.gov/21475140/
The only randomised controlled trial of whether body fat returns after it is removed. 32 non-obese women, small-volume liposuction against no treatment, followed one year with DXA and MRI. Source for the finding that body fat was restored by one year and redistributed from thigh to abdomen. Studied liposuction, not injection lipolysis.
Swanson E. Photographic measurements in 301 cases of liposuction and abdominoplasty reveal fat reduction without redistribution. Plast Reconstr Surg. 2012;130(2):311e-322e. https://pubmed.ncbi.nlm.nih.gov/22842428/
Prospective single-surgeon non-randomised series of 301 procedures, with a subset of 46 followed a year or more, concluding there was no evidence of fat regrowth. Cited as the counterweight to the randomised trial above. The author is a practising liposuction surgeon reporting on his own patients.
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